FDA 510(k) Applications for Medical Device:
Indicator, Physical/Chemical Sterilization Process
| FDA 510(k) Number | Applicant | Address | City / Country | State / Province | Postal Code |
|---|---|---|---|---|---|
| K193254 | 3M Company |
3M Center, Building 275-5W-06 | St. Paul | MN | 55144 |
| K220942 | 3M Company |
2510 Conway Avenue, Bldg. 275-5W-06 | Saint Paul | MN | 55144-1000 |
| K020589 | 3M COMPANY |
3M CENTER, BLDG. 275-5W-06 | ST. PAUL | MN | 55133-3275 |
| K093199 | 3M COMPANY |
3M CENTER, BLDG. 275-5W-06 | ST. PAUL | MN | 55144-1000 |
| K183211 | 3M Company |
3M Center, Building 275-5W-06 | St. Paul | MN | 55144 |
| K192937 | 3M Company |
3M Center, Building 275-5W-06 | St. Paul | MN | 55144 |
| K170321 | 3M COMPANY |
3M CENTER | ST.PAUL | MN | 55144 |
| K203458 | 3M Company |
3M Center, Building 275-5W-06 | St. Paul | MN | 55144 |
| K150622 | 3M Company |
3M Center, Building 275-5W-06 | St.Paul | MN | 55144 |
| K170563 | 3M Company |
3M Center, Building 275-5W-06 | St. Paul | MN | 55144 |
| K183209 | 3M Company |
3M Center, Building 275-5W-06 | St. Paul | MN | 55144 |
| K203285 | 3M Company |
3M Center, Building 275-5W-06 | St. Pauk | MN | 55144 |
| K150694 | 3M Company |
3M Center, Building 275-5W-06 | St. Paul | MN | 55144 |
| K150477 | 3M COMPANY |
3M CENTER, BUILDING 275-5W-06 | ST. PAUL | MN | 55144 |
| K101528 | 3M COMPANY |
3M CENTER, BLDG. 275-5W-06 | ST. PAUL | MN | 55144-1000 |
| K220564 | 3M Company |
2510 Conway Avenue, Bldg. 275-5W-06 | St. Paul | MN | 55144-1000 |
| K212081 | 3M Company |
3M Center, Building 275-5W-06 | St. Paul | MN | 55144 |
| K222152 | 3M Company |
2510 Conway Avenue, Bldg. 275-5W-06 | St. Paul | MN | 55144-1000 |
| K191236 | 3M Company |
3M Center, Building 275-5W-06 | St. Paul | MN | 55144 |
| K222508 | 3M Company |
2510 Conway Avenue, Bldg. 275-5W-06 | St. Paul | MN | 55144-1000 |
| K192673 | 3M Company |
3M Center, Building 275-5W-06 | St. Paul | MN | 55144 |
| K101249 | 3M COMPANY |
3M CENTER, BLDG. 275-05-W-06 | ST. PAUL | MN | 55144-1000 |
| K040742 | ADVANCED STERILIZATION PRODUCTS |
33 TECHNOLOGY DR. | IRVINE | CA | 92618 |
| K111518 | ADVANCED STERILIZATION PRODUCTS |
33 TECHNOLOGY DR. | IRVINE | CA | 92618 |
| K103218 | ADVANCED STERILIZATION PRODUCTS |
33 TECHNOLOGY DR. | IRVINE | CA | 92618 |
| K022441 | ADVANCED STERILIZATION PRODUCTS |
33 TECHNOLOGY DR. | IRVINE | CA | 92618 |
| K103219 | ADVANCED STERILIZATION PRODUCTS |
33 TECHNOLOGY DR. | IRVINE | CA | 92618 |
| K111519 | ADVANCED STERILIZATION PRODUCTS |
33 TECHNOLOGY DR. | IRVINE | CA | 92618 |
| K061738 | ALBERT BROWNE LTD. |
49 PLAIN STREET | NORTH ATTLEBORO | MA | 02760 |
| K060103 | ALBERT BROWNE LTD. |
49 PLAIN ST. | NORTH ATTLEBORO | MA | 02760 |
| K991709 | ALBERT BROWNE LTD. |
49 PLAIN ST. | NORTH ATTLEBORO | MA | 02760 |
| K981054 | ALBERT BROWNE LTD. |
49 PLAIN ST. | NORTH ATTLEBORO | MA | 02760 |
| K012335 | ALBERT BROWNE LTD. |
49 PLAIN ST. | NORTH ATTLEBORO | MA | 02760 |
| K991418 | ALBERT BROWNE LTD. |
49 PLAIN ST. | NORTH ATTLEBORO | MA | 02760 |
| K971369 | ALBERT BROWNE LTD. |
49 PLAIN ST. | NORTH ATTLEBORO | MA | 02760 |
| K992767 | ALBERT BROWNE LTD. |
49 PLAIN ST. | NORTH ATTLEBORO | MA | 02760 |
| K984616 | ALBERT BROWNE LTD. |
49 PLAIN ST. | NORTH ATTLEBORO | MA | 02760 |
| K984613 | ALBERT BROWNE LTD. |
49 PLAIN ST. | NORTH ATTLEBORO | MA | 02760 |
| K002741 | ALBERT BROWNE LTD. |
49 PLAIN ST. | NORTH ATTLEBORO | MA | 02760 |
| K032801 | ALBERT BROWNE LTD. |
49 PLAIN ST. | NORTH ATTLEBORO | MA | 02760 |
| K063285 | ALBERT BROWNE LTD. |
49 PLAIN STREET | NORTH ATTLEBORO | MA | 02760 |
| K060066 | ALBERT BROWNE LTD. |
49 PLAIN ST. | NORTH ATTLEBORO | MA | 02760 |
| K053479 | ALBERT BROWNE LTD. |
49 PLAIN STREET | NORTH ATTLEBORO | MA | 02760 |
| K051101 | ALBERT BROWNE LTD. |
49 PLAIN STREET | NORTH ATTLEBORO | MA | 02760 |
| K971888 | ALDEN SCIENTIFIC, INC. |
360 COLD SPRING AVE. | SPRINGFIELD | MA | 01089 |
| K200334 | Andersen Sterilizers, Inc. |
3154 Caroline Drive | Haw River | NC | 27258 |
| K150645 | ANDERSEN STERILIZERS, INC. |
3154 CAROLINE DRIVE | HAW RIVER | NC | 27258 |
| K150644 | ANDERSEN STERILIZERS, INC. |
3154 CAROLINE DRIVE | HAW RIVER | NC | 27258 |
| K170439 | Andersen Sterilizers, Inc. |
3154 Caroline Drive | Haw River | NC | 27258 |
| K170426 | Andersen Sterilizers,Inc. |
3154 Caroline Drive | Haw River | NC | 27258 |
| K970918 | BOARD OF DIRECTORS, ALBERT BROWNE LTD. |
49 PLAIN ST. | NORTH ATTLEBORO | MA | 02760 |
| K971971 | BOARD OF DIRECTORS, ALBERT BROWNE LTD. |
49 PLAIN ST. | NORTH ATTLEBORO | MA | 02760 |
| K161024 | Canadian Technical Tape, Ltd. |
455 Cote-Vertu Blvd | Montreal | h4n 1E8 | |
| K140940 | CANADIAN TECHNICAL TAPE, LTD. |
125 HIGHPOWER ROAD | ROCHESTER | NY | 14623 |
| K982151 | CASE MEDICAL, INC. |
65 RAILROAD AVE. | RIDGEFIELD | NJ | 07657-0402 |
| K960089 | COTTRELL, LTD. |
49 PLAIN ST. | NORTH ATTLEBORO | MA | 02760-4153 |
| K143520 | CROSSTEX |
6789 WEST HENRIETTA ROAD | RUSH | NY | 14543 |
| K133204 | CROSSTEX INTERNATIONAL |
6789 WEST HENRIETTA ROAD | RUSH | NY | 14543 |
| K140566 | CROSSTEX INTERNATIONAL |
6789 WEST HENRIETTA ROAD | RUSH | NY | 14543 |
| K200096 | Crosstex International, Inc. (A Cantel Medical Company) |
6789 W. Henrietta Road | Rush | NY | 14543 |
| K100891 | DANA PRODUCTS, INC. |
7 COREY DR. | SOUTH BARINGTON | IL | 60010 |
| K130135 | DANA PRODUCTS, INC. |
7 COREY DR. | SOUTH BARINGTON | IL | 60010 |
| K120592 | DANA PRODUCTS, INC. |
7 COREY DR. | SOUTH BARINGTON | IL | 60010 |
| K102761 | DANA PRODUCTS, INC. |
7 COREY DR. | SOUTH BARRINGTON | IL | 60010 |
| K110253 | DANA PRODUCTS, INC. |
7 COREY DR. | SOUTH BARRINGTON | IL | 60010 |
| K012195 | DANA PRODUCTS, INC. |
7 COREY DR. | SOUTH BARINGTON | IL | 60010 |
| K031647 | GETINGE USA, INC |
1777 EAST HENRIETTA RD. | ROCHESTER | NY | 14623-3133 |
| K070419 | HACH COMPANY |
23575 COUNTY ROAD 106 | ELKHART | IN | 46514 |
| K110369 | INDILAB, INC. |
10367 FRANKLIN AVE. | FRANKLIN PARK | IL | 60131 |
| K191741 | Intertape Polymer Inc. |
100 Paramount Dr Suite 300 | Sarasota | FL | 34232 |
| K181788 | Kem Medical Products Corp. |
400 Broadhollow Road, Suite 2 | Farmingdale | NY | 11735 |
| K974415 | KIMBERLY-CLARK CORP. |
1400 HOLCOMB BRIDGE RD. | ROSWELL | GA | 30076 |
| K152394 | MEDIVATORS INC. |
14605 28TH AVE NORTH | MINNEAPOLIS | MN | 55447 |
| K013228 | MINNESOTA MINING AND MFG. CO. |
5353 WAYZATA BLVD. | MINNEAPOLIS | MN | 55416 |
| K000355 | MINNESOTA MINING AND MFG. CO. |
3M CENTER | ST. PAUL | MN | 55144-1000 |
| K103126 | NANOSONICS LIMITED |
24/566 GARDENERS ROAD | ALEXANDRIA, NSW | 2015 | |
| K101580 | NEV'S INK, INC |
2500 W. SUNSET DR | WAUKESHA | WI | 53189-6326 |
| K983451 | NORTH AMERICAN SCIENCE ASSOC., INC. |
2261 TRACY RD. | NORTHWOOD | OH | 43619 |
| K132291 | NORTH AMERICAN SCIENCE ASSOC., INC. |
6750 WALES RD. | NORTHWOOD | OH | 43619 |
| K212592 | Propper Manufacturing Co., Inc. |
36-04 Skillman Avenue | Long Island City | NY | 11101 |
| K222137 | Propper Manufacturing Co., Inc. |
36-04 Skillman Avenue | Long Island City | NY | 11101 |
| K210553 | Propper Manufacturing Co., Inc. |
36-04 Skillman Avenue | Long Island City | NY | 11101 |
| K210866 | Propper Manufacturing Co., Inc. |
36-04 Skillman Avenue | Long Island City | NY | 11101 |
| K102894 | PROPPER MFG. CO., INC. |
36-04 SKILLMAN AVE. | LONG ISLAND CITY | NY | 11101 |
| K961156 | PROPPER MFG. CO., INC. |
36-04 SKILLMAN AVE. | LONG ISLAND CITY | NY | 11101 |
| K082620 | PROPPER MFG. CO., INC. |
36-04 SKILLMAN AVE. | LONG ISLAND CITY | NY | 11101 |
| K991276 | PROPPER MFG. CO., INC. |
36-04 SKILLMAN AVE. | LONG ISLAND CITY | NY | 11101 |
| K973585 | PROPPER MFG. CO., INC. |
36-04 SKILLMAN AVE. | LONG ISLAND CITY | NY | 11101 |
| K031152 | PROPPER MFG. CO., INC. |
36-04 SKILLMAN AVE. | LONG ISLAND CITY | NY | 11101 |
| K111453 | PROPPER MFG. CO., INC. |
36-04 SKILLMAN AVE. | LONG ISLAND CITY | NY | 11101 |
| K952995 | PYMAH CORP. |
500 ROUTE 202 NORTH | FLEMINGTON | NJ | 08822-6026 |
| K062651 | RAVEN BIOLOGICAL LABORATORIES, INC. |
8607 PARK DR. | OMAHA | NE | 68127 |
| K080307 | RAVEN LABORATORIES |
8607 PARK DR. | OMAHA | NE | 68127 |
| K992341 | SERIM RESEARCH CORP. |
23565 REEDY DR. | ELKHART | IN | 46514 |
| K120652 | SERIM RESEARCH CORP. |
3506 Reedy Dr | ELKHART | IN | 46514 |
| K092346 | SERIM RESEARCH CORP. |
3506 REEDY DR. | ELKHART | IN | 46561 |
| K083295 | SERIM RESEARCH CORP. |
3506 REEDY DR. | ELKHART | IN | 46561 |
| K082352 | SERIM RESEARCH CORP. |
3506 REEDY DRIVE | ELKHART | IN | 46514 |
| K081370 | SERIM RESEARCH CORP. |
3506 REEDY ST. | ELKHART | IN | 46561 |
| K052388 | SERIM RESEARCH CORP. |
23565 REEDY DR. | ELKHART | IN | 46514 |
| K972035 | SERIM RESEARCH CORP. |
P.O. BOX 4002 | ELKHART | IN | 46514-0002 |
| K192445 | Serim Research Corporation |
3506 Reedy Drive | Elkhard | IN | 46514 |
| K202565 | Serim Research Corporation |
3506 Reedy Drive | Elkhart | IN | 46514 |
| K130211 | SPS MEDICAL SUPPLY CORP. |
6789 WEST HENRIETTA RD. | RUSH | NY | 14543 |
| K041017 | SPS MEDICAL SUPPLY CORP. |
6789 WEST HENRIETTA RD. | RUSH | NY | 14543 |
| K102363 | SPS MEDICAL SUPPLY CORP. |
6789 WEST HENRIETTA RD. | RUSH | NY | 14543 |
| K030680 | SPS MEDICAL SUPPLY CORP. |
6789 WEST HENRIETTA RD. | RUSH | NY | 14543 |
| K090650 | SPS MEDICAL SUPPLY CORP. |
6789 WEST HENRIETTA RD. | RUSH | NY | 14543 |
| K063799 | SPS MEDICAL SUPPLY CORP. |
6789 WEST HENRIETTA RD. | RUSH | NY | 14543 |
| K020409 | SPS MEDICAL SUPPLY CORP. |
6789 WEST HENRIETTA RD. | RUSH | NY | 14543 |
| K110152 | SPSMEDICAL SUPPLY CORP. |
6789 WEST HENRIETTA RD | RUSH | NY | 14543 |
| K191999 | Sterilucent, Inc. |
1400 Marshall St. NE | Minneapolis | MN | 55413 |
| K231488 | STERIS |
5960 Heisley Rd | Mentor | OH | 44060 |
| K213412 | STERIS Corparation |
5960 Heisley Road | Mentor | OH | 44060 |
| K120435 | STERIS Corporation |
5960 Heisley Road | Mentor | OH | 44060 |
| K081427 | STERIS Corporation |
5960 Heisley Road | Mentor | OH | 44060 |
| K080750 | STERIS Corporation |
5960 Heisley Road | Mentor | OH | 44060 |
| K192020 | STERIS Corporation |
5960 Heisley Road | Mentor | OH | 44077 |
| K182724 | STERIS Corporation |
5960 Heisley Rd. | Mentor | OH | 44060 |
| K172472 | STERIS Corporation |
5960 Heisley Road | Mentor | OH | 44060 |
| K230558 | STERIS Corporation |
5976 Heisley Road | Mentor | OH | 44060 |
| K143333 | STERIS Corporation |
5960 Heisley Road | Mentor | OH | 44060 |
| K081600 | STERIS Corporation |
5960 Heisley Road | Mentor | OH | 44060 |
| K112256 | STERIS Corporation |
5960 Heisley Road | Mentor | OH | 44060 |
| K102217 | STERIS Corporation |
5960 Heisley Road | Mentor | OH | 44060 |
| K043482 | STERIS Corporation |
5960 Heisley Road | Mentor | OH | 44060 |
| K103053 | STERIS Corporation |
5960 Heisley Road | Mentor | OH | 44060 |
| K071895 | STERIS Corporation |
5960 Heisley Road | Mentor | OH | 44060 |
| K083643 | STERIS Corporation |
5960 Heisley Road | Mentor | OH | 44060 |
| K103331 | STERIS Corporation |
5960 Heisley Road | Mentor | OH | 44060 |
| K073683 | STERIS Corporation |
5960 Heisley Road | Mentor | OH | 44060 |
| K070895 | STERIS Corporation |
5960 Heisley Road | Mentor | OH | 44060 |
| K173428 | STERIS Corporation |
5976 Heisley Rd | Mentor | OH | 44060 |
| K102296 | STERIS Corporation |
5960 Heisley Road | Mentor | OH | 44060 |
| K140515 | STERIS Corporation |
5960 Heisley Road | Mentor | OH | 44060 |
| K130160 | STERIS Corporation |
5960 Heisley Road | Mentor | OH | 44060 |
| K162758 | STERIS Corporation |
5960 Heisley Rd | Mentor | OH | 44060 |
| K070461 | STERIS Corporation |
5960 Heisley Road | Mentor | OH | 44060 |
| K152630 | STERIS CORPORATION |
5960 HEISLEY ROAD | MENTOR | OH | 44060 |
| K162631 | STERIS CORPORATION |
5960 HEISLEY ROAD | MENTOR | OH | 44060 |
| K091174 | STERIS Corporation |
5960 Heisley Road | Mentor | OH | 44060 |
| K072510 | STERIS Corporation |
5960 Heisley Road | Mentor | OH | 44060 |
| K183293 | STERIS Corporation |
5960 Heisley Rd | Mentor | OH | 44060 |
| K160485 | STERIS CORPORATION |
5960 HEISLEY ROAD | MENTOR | OH | 44060 |
| K172753 | Steris Corporation |
5960 Heisley Road | Mentor | OH | 44060 |
| K172746 | STERIS Corporation |
5960 Heisley Road | Mentor | OH | 44060 |
| K183295 | Steris Corporations |
5960 Heisley Road | Mentor | OH | 44060 |
| K200252 | SteriTec Products MFG Co Inc |
74 Inverness Drive East | Englewood | CO | 80112 |
| K952244 | STERITEC PRODUCTS MFG. CO., INC. |
680 ATCHISON WAY | CASTLE ROCK | CO | 80104 |
| K972300 | STERITEC PRODUCTS MFG. CO., INC. |
680 ATCHISON WAY | CASTLE ROCK | CO | 80104 |
| K072408 | STERITEC PRODUCTS MFG. CO., INC. |
599 TOPEKA WAY | CASTLE ROCK | CO | 80109 |
| K103000 | STERITEC PRODUCTS MFG. CO., INC. |
74 INVERNESS DRIVE EAST | ENGLEWOOD | CO | 80112 |
| K000502 | STERITEC PRODUCTS MFG. CO., INC. |
599 TOPEKA WAY | CASTLE ROCK | CO | 80104 |
| K982188 | STERITEC PRODUCTS MFG. CO., INC. |
680 ATCHISON WAY | CASTLE ROCK | CO | 80104 |
| K990246 | STERITEC PRODUCTS MFG. CO., INC. |
680 ATCHISON WAY | CASTLE ROCK | CO | 80104 |
| K955426 | STERITEC PRODUCTS MFG. CO., INC. |
680 ATCHISON WAY | CASTLE ROCK | CO | 80104 |
| K982547 | STERITEC PRODUCTS MFG. CO., INC. |
680 ATCHISON WAY | CASTLE ROCK | CO | 80104 |
| K965212 | STERITEC PRODUCTS MFG. CO., INC. |
680 ATCHISON WAY, STE #600 | CASTLE ROCK | CO | 80104 |
| K953122 | STERITEC PRODUCTS MFG. CO., INC. |
680 ATCHISON WAY | CASTLE ROCK | CO | 80104 |
| K132372 | STERITEC PRODUCTS MFG. CO., INC. |
74 INVERNESS DRIVE EAST | ENGLEWOOD | CO | 80112 |
| K122945 | STERITEC PRODUCTS MFG. CO., INC. |
74 INVERNESS DRIVE EAST | ENGLEWOOD | CO | 80112 |
| K960441 | STERITEC PRODUCTS MFG. CO., INC. |
7792 SOUTH URAVAN CT. | AURORA | CO | 80016-1847 |
| K122555 | STERITEC PRODUCTS MFG. CO., INC. |
74 INVERNESS DRIVE EAST | ENGLEWOOD | CO | 80112 |
| K024293 | STERITEC PRODUCTS, INC. |
599 TOPEKA WAY, SUITE 700 | CASTLE ROCK | CO | 80109 |
| K010534 | STERITEC PRODUCTS, INC. |
599 TOPEKA WAY, SUITE 700 | CASTLE ROCK | CO | 80104 |
| K003533 | STERITEC PRODUCTS, INC. |
599 TOPEKA WAY, SUITE 700 | CASTLE ROCK | CO | 80104 |
| K083650 | STERITEC PRODUCTS, INC. |
599 TOPEKA WAY, SUITE 400 | CASTLE ROCK | CO | 80109 |
| K002861 | STERITEC PRODUCTS, INC. |
599 TOPEKA WAY, SUITE 700 | CASTLE ROCK | CO | 80104 |
| K080136 | STERITEC PRODUCTS, INC. |
599 TOPEKA WAY, SUITE 400 | CASTLE ROCK | CO | 80109 |
| K012732 | STERITEC PRODUCTS, INC. |
599 TOPEKA WAY, SUITE 700 | CASTLE ROCK | CO | 80104 |
| K003002 | STERITEC PRODUCTS, INC. |
599 TOPEKA WAY, SUITE 700 | CASTLE ROCK | CO | 80104 |
| K001649 | STERITEC PRODUCTS, INC. |
599 TOPEKA WAY, SUITE 700 | CASTLE ROCK | CO | 80104 |
| K052516 | STERITEC PRODUCTS, INC. |
599 TOPEKA WAY, SUITE 400 | CASTLE ROCK | CO | 80109 |
| K040901 | STERITEC PRODUCTS, INC. |
599 TOPEKA WAY, SUITE 400 | CASTLE ROCK | CO | 80109 |
| K001444 | STERITEC PRODUCTS, INC. |
599 TOPEKA WAY, SUITE 700 | CASTLE ROCK | CO | 80104 |
| K020612 | SULTAN CHEMISTS, INC. |
85 WEST FOREST AVE. | ENGLEWOOD | NJ | 07631 |
| K021161 | TECHNOLOGIES OF STERILIZATION WITH OXONE, TSO3 INC |
33 BLACK WATCH TRAIL | FAIRPORT | NY | 14450 |
| K200272 | Terragene SA |
Ruta Nacional No. 9, Km 280, Parque Industrial Micropi | Alvear | 2130 | |
| K220778 | True Indicating LLC |
946 Kane St | Toledo | OH | 43612 |
| K141698 | TSO3 INC. |
512F NE 81ST STREET, SUITE 110 | VANCOUVER | WA | 98665 |
| K143629 | U&U MEDICAL TECHNOLOGY CO., LTD |
DONGZHOU VILLAGE, HENGSHANQIAO | CHANGZHOU | 213119 | |
| K171823 | U&U Medical Technology Co., Ltd |
Dongzhou Village | Changzhou | 213119 |
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