FDA 510(k) Applications for Medical Device:
Drape, Surgical
| FDA 510(k) Number | Applicant | Address | City / Country | State / Province | Postal Code |
|---|---|---|---|---|---|
| K043015 | 3L MEDICAL PRODUCTS CO., LTD. |
1800 CENTURY PARK EAST | CENTURY CITY | CA | 90067 |
| K222578 | 3M Company |
2510 Conway Ave. | St. Paul | MN | 55144 |
| K031287 | 3M COMPANY |
3M CENTER, BLDG. 275-5W-06 | ST. PAUL | MN | 55133-3275 |
| K140250 | 3M HEALTH CARE |
3M CENTER, 2510 CONWAY AVE. | ST. PAUL | MN | 55144 |
| K140330 | 3M HEALTH CARE |
BUILDING 275-5W-06 | ST PAUL | MN | 55144-1000 |
| K102861 | A PLUS INTERNATIONAL, INC. |
5138 EUCALYPTUS AVE., | CHINO | CA | 91710 |
| K012168 | ADVANCE MEDICAL DESIGNS, INC. |
1241 ATLANTA INDUSTRIAL DR. | MARIETTA | GA | 30066 |
| K053495 | ADVANCE MEDICAL DESIGNS, INC. |
1241 ATLANTA INDUSTRIAL DR. | MARIETTA | GA | 30066 |
| K003670 | ADVANCE MEDICAL DESIGNS, INC. |
1241 ATLANTA INDUSTRIAL DR. | MARIETTA | GA | 30066 |
| K011422 | ADVANCE MEDICAL DESIGNS, INC. |
1241 ATLANTA INDUSTRIAL DR. | MARIETTA | GA | 30066 |
| K010711 | ADVANCED SURGICAL CONCEPTS (ASC) |
49 PLAIN ST. | NORTH ATTLEBORO | MA | 02760 |
| K131571 | ADVANCED VASCULAR DYNAMICS |
4252 SE International Way Ste F | Milwaukie | OR | 97222 |
| K002419 | ALLEGIANCE HEALTHCARE COPORATION |
1500 WAUKERGAN RD. | MCGAW PARK | IL | 60085 |
| K964125 | ALLEGIANCE HEALTHCARE CORP. |
1500 WAUKEGAN RD.- K | MCGRAW PARK | IL | 60085 |
| K000417 | ALLEGIANCE HEALTHCARE CORP. |
1500 WAUKEGAN RD.- K | MCGRAW PARK | IL | 60085 |
| K970554 | ALLEGIANCE HEALTHCARE CORP. |
1500 WAUKEGAN RD.- K | MCGRAW PARK | IL | 60085 |
| K993795 | ALLEGIANCE HEALTHCARE CORP. |
1500 WAUKEGAN RD.- K | MCGRAW PARK | IL | 60085 |
| K981818 | ALLEGIANCE HEALTHCARE CORP. |
1500 WAUKEGAN RD.- K | MCGRAW PARK | IL | 60085 |
| K023425 | ALLEGIANCE HEALTHCARE CORP. |
1500 WAUKEGAN RD. MPWM-1E | MCGAW PARK | IL | 60085 |
| K002508 | ALLEGIANCE HEALTHCARE CORP. |
1500 WAUKEGAN RD.- K | MCGRAW PARK | IL | 60085 |
| K001667 | ALLEGIANCE HEALTHCARE CORP. |
1500 WAUKEGAN RD.- K | MCGRAW PARK | IL | 60085 |
| K023419 | ALLEGIANCE HEALTHCARE CORP. |
1500 WAUKEGAN RD. MPWM-1E | MCGAW PARK | IL | 60085 |
| K990253 | AMBA MEDICAL LTD. |
BONVILLE ROAD | BRISTOL BS4 5QH | BS4 5QH | |
| K972187 | AMERICAN SEAL CO. |
25029 VIKING ST. | HAYWARD | CA | 94545 |
| K031889 | APPLIED MEDICAL RESOURCES CORP. |
22872 Avenida Empresa | Rancho Santa Margarita | CA | 92688 |
| K020435 | APPLIED MEDICAL RESOURCES CORP. |
22872 Avenida Empresa | Rancho Santa Margarita | CA | 92688 |
| K071491 | ARROW INTL., INC. |
2400 BERNVILLE RD. | READING | PA | 19605 |
| K061422 | AUSTIN MEDICAL, INC. |
3460 POINTE CREEK CT. | BONITA SPRINGS | FL | 34134-2015 |
| K202208 | Avery Dennison Belgie BVBA |
Tieblokkenlaan, 1 | Turnhout | 2300 | |
| K230645 | Avery Dennison Medical Ltd. |
IDA Business Park, Ballinalee Road | Longford | N39 RC80 | |
| K981823 | BALDUR SYSTEMS CORP. |
25 HERITAGE DR. | ASHEVILLE | NC | 28806 |
| K010572 | BECTON DICKINSON AND CO. |
7575 COMMERCE COURT | SARASOTA | FL | 34243-3212 |
| K991667 | BROADLINE MEDICAL INDUSTRIES |
1432 SHIRE CIRCLE | INVERNESS | IL | 60067 |
| K083424 | BUSSE HOSIPITAL DISPOSABLES |
75 ARKAY DR | HAUPPAUGE | NY | 11788 |
| K082297 | BUSSE HOSPITAL DISPOSABLES, INC. |
75 ARKAY DR. | HAUPPAUGE | NY | 11788 |
| K092212 | BUSSE HOSPITAL DISPOSABLES, INC. |
75 ARKAY DR. | HAUPPAUGE | NY | 11788 |
| K093909 | BUSSE HOSPITAL DISPOSABLES, INC. |
75 ARKAY DR. | HAUPPAUGE | NY | 11788 |
| K130404 | CARDINAL HEALTH 200, LLC |
1430 WAUKEGAN ROAD | WAUKEGAN | IL | 60085 |
| K061762 | CARDINAL HEALTH, INC. |
1500 WAUKEGAN ROAD | MCGAW PARK | IL | 60085 |
| K122000 | CHANGZHOU HOLYMED PRODUCTS CO LTD |
528 CHANGWU ROAD SOUTH | CHANGHOU | 213167 | |
| K001858 | CHINA NANTONG GUANGDA TEXTILE CO., LTD. |
1532 LONGMEADOW RD. | BARTLETT | IL | 60103 |
| K112378 | COBES INDUSTRIES CO., LTD. |
3500 SOUTH DUPONT HIGHWAY | DOVER | DE | 19901 |
| K002691 | COM-MED INTERNATIONAL, INC. |
P.O. BOX 848 | GRAYSLAKE | IL | 60030 |
| K970185 | CONTOUR FABRICATORS, INC. |
4100 E. BALDWIN AVE. | GRAND BLANC | MI | 48439 |
| K200238 | ControlRad, Inc |
275 Scientific Drive NW #1100 | Norcross | GA | 30092 |
| K163556 | COVALON TECHNOLOGIES, INC. |
1660 TECH AVENUE | MISSISSSAUGA | L4W 5S7 | |
| K140064 | COVIDIEN |
60 MIDDLETOWN DR | NORTH HAVEN | CT | 06473 |
| K994199 | CUSTOM MEDICAL PRODUCTS, INC. |
1 HOLIDAY INN DR. | ASHEVILLE | NC | 28806 |
| K960242 | CUSTOM PACK RELIABILITY |
4207 VINELAND ROAD, M-1 | ORLANDO | FL | 32811 |
| K974647 | CUSTOMED, INC. |
CALLE IGUALDAD #7 | FAJARDO | PR | 00738 |
| K121436 | DAS MEDICAL, LLC |
100 ROSECREST LANE | COLUMBUS | MS | 39701 |
| K994211 | DENTSPLY INTL. |
901 WEST OAKTON ST. | DES PLAINES | IL | 60018-1884 |
| K030908 | DEROYAL |
200 DEBUSK LN. | POWELL | TN | 37849 |
| K030365 | DEROYAL INDUSTRIES, INC. |
200 DEBUSK LN. | POWELL | TN | 37849 |
| K083320 | DUKAL CORP. |
5 PLANT AVE | HAUPPAUGE | NY | 11788 |
| K012957 | DYNAREX CORP. |
7736 WOODSIDE COURT | MAINEVILLE | OH | 45039 |
| K001994 | EAGLE ENDOSCOPIC, INC. |
700 SEALS RD. | BARTONVILLE | TX | 76226 |
| K101689 | EXACT MEDICAL MANUFACTURING, INC |
1083 DELAWARE AVE | BUFFALO | NY | 14209 |
| K101598 | EXACT MEDICAL MANUFACTURING, INC |
1083 DELAWARE AVE | BUFFALO | NY | 14209 |
| K101688 | EXACT MEDICAL MANUFACTURING, INC |
1083 DELAWARE AVE | BUFFALO | NY | 14209 |
| K121919 | EXACT MEDICAL MANUFACTURING, INC |
1083 DELAWARE AVE | BUFFALO | NY | 14209 |
| K955749 | FLYNT AMTEX, INC. |
673 GILMER ST. | BURLINGTON | NC | 27217 |
| K041224 | FOOTHILLS INDUSTRIES, INC. |
172 LUKIN ST. | MARION | NC | 28752 |
| K133080 | FOSHAN NANHAI PLUS MEDICAL CO., LTD. |
3500 SOUTH DUPONT HIGHWAY | DOVER | DE | 19901 |
| K980210 | GEL-LITE, L.L.C. |
4820 EXECUTIVE PARKCT., #110 | JACKSONVILLE | FL | 32216 |
| K111458 | GRI MEDICAL & ELECTRONIC TECHNOLOGY CO., LTD. |
717 LAKEGLEN DRIVE | SUWANEE | GA | 30024 |
| K140195 | GRIFFITH-LUCAS LLC |
7TH FLOOR, JINGUI BUSINESS BUILDING NO.982 | GUANGZHOU, GUANGDONG | 510420 | |
| K002702 | GYRUS ENT L.L.C. |
2925 APPLING RD. | BARTLETT | TN | 38133 |
| K050508 | HAYWOOD VOCATIONAL OPPORTUNITIES |
56 SCATES ST. | WAYNESVILLE | NC | 28786 |
| K094016 | HINSON AND HALE MEDICAL TECHNOLOGIES, INC |
7809 ADELAIDE DRIVE | AUSTIN | TX | 78739 |
| K041077 | IMALUX CORPORATION |
1771 EAST 30TH STREET | CLEVELAND | OH | 44114 |
| K013958 | INDUS TEXTILES, INC. |
P.O. BOX 848 | GRAYSLAKE | IL | 60030 |
| K100208 | INTERNATIONAL MEDSURG CONNECTION |
935 N PLUM GROVE RD, STE F | SCHAUMBURG | IL | 60173 |
| K100991 | INTERNATIONAL MEDSURG CONNECTION |
935 N. PLUM GROVE ROAD, | SCHAUMBURG | IL | 60173 |
| K971159 | INTERNATIONAL MEDSURG CONNECTION |
1000 E. WOODFIELD RD. | SCHAUMBERG | IL | 60173 |
| K052169 | INTERNATIONAL MEDSURG CONNECTION, INC. |
935 NORTH PLUM GROVE RD. | SCHAUMBURG | IL | 60173 |
| K042893 | INTERNATIONAL MEDSURG CONNECTION, INC. |
PO BOX 100624 | CUDAHY | WI | 53110 |
| K050538 | INTL. MEDSURG CONNECTION, INC. |
935 N. PLUM GROVE RD. STE. F | SCHAUMBURG | IL | 60173-4770 |
| K062480 | JOYKEY INDUSTRYIAL LTD. |
2904 N. BOLDT DRIVE | FLAGSTAFF | AZ | 86001 |
| K083234 | KIMBERLY-CLARK CORP. |
172 CONDUCTOR DRIVE | DAWSONVILLE | GA | 30534 |
| K102666 | KIMBERLY-CLARK CORP. |
1400 HOLCOMB BRIDGE RD. | ROSWELL | GA | 30076-2199 |
| K112136 | KUNSHAN JIEHONG NONWOVEN PRODUCT CO., LTD. |
1340 WEST PENNSYLVANIA AVE | SAN DIEGO | CA | 92103 |
| K031362 | LAC MAC, LTD. |
10907 WAREHAM COURT | AUSTIN | TX | 78739 |
| K020393 | MASTER & FRANK ENTERPRSES CO.LTD. |
15F-1 NO 57 SEC 2 | TAIPEI | ||
| K955872 | MEDAL INTL. SALES CO., LLC. |
100 EAST 15TH ST. | FT. WORTH | TX | 76102 |
| K042526 | MEDICAL ACTION INDUSTRIES, INC. |
25 HEYWOOD RD. | ARDEN | NC | 28704 |
| K000442 | MEDICAL CONCEPTS DEVELOPMENT, INC. |
2500 VENTURA DR. | WOODBURY | MN | 55125-3927 |
| K020581 | MEDICAL CONCEPTS DEVELOPMENT, INC. |
2500 VENTURA DR. | WOODBURY | MN | 55125-3927 |
| K954824 | MEDICAL CREATIVE TECHNOLOGIES, INC. |
2950-N ADVANCE LN. | COLMAR | PA | 18915-9727 |
| K974672 | MEDICAL SPECIALTY INNOVATIONS, INC. (MSI) |
55 NORTHERN BLVD. | GREAT NECK | NY | 11021 |
| K052833 | MEDLINE INDUSTRIES, INC. |
ONE MEDLINE PLACE | MUNDELEIN | IL | 60060 |
| K023432 | MEDLINE INDUSTRIES, INC. |
ONE MEDLINE PLACE | MUNDELEIN | IL | 60060 |
| K964142 | MEDLINE INDUSTRIES, INC. |
ONE MEDLINE PLACE | MUNDELEIN | IL | 60060-4486 |
| K032666 | MEDLINE INDUSTRIES, INC. |
1170 S. NORTHPOINT BLVD. | WAUKEGAN | IL | 60085 |
| K962205 | MEDLINE INDUSTRIES, INC. |
ONE MEDLINE PLACE | MUNDELEIN | IL | 60060-4486 |
| K973146 | MENTOR OPHTHALMICS, INC. |
5425 HOLLISTER AVE. | SANTA BARBARA | CA | 93111 |
| K012237 | MERCAN AB |
10907 WAREHAM COURT | AUSTIN | TX | 78739 |
| K963675 | MICRO-MEDICAL DEVICES, INC. |
317 PARAGON WAY | CASTLE ROCK | CO | 80104 |
| K050322 | MICROTEK MEDICAL, INC. |
512 LEHMBERG RD. | COLUMBUS | MS | 39702 |
| K060200 | MICROTEK MEDICAL, INC. |
512 LEHMBERG RD. | COLUMBUS | MS | 39702 |
| K041846 | MINRAD, INC. |
847 MAIN ST. | BUFFALO | NY | 14203 |
| K031131 | MOLNLYCKE HEALTH CARE |
826 NEWTON YARDLEY RD. | NEWTON | PA | 18940 |
| K051625 | MOLNLYCKE HEALTH CARE, INC. |
826 NEWTOWN-YARDLEY RD. | NEWTOWN | PA | 18940 |
| K000906 | MOLNLYCKE HEALTH CARE, INC. |
500 BALDWIN TOWER | EDDYSTONE | PA | 19022 |
| K991548 | NOVED MEDICAL |
168 AVENIDA DEL MAR, SUITE 120 | SAN CLEMENTE | CA | 92672 |
| K042977 | ODYSSEY MEDICAL, INC. |
5828 SHELBY OAKS DR. | MEMPHIS | TN | 38134 |
| K971089 | OPPORTUNITY, INC. |
1200 OLD SKOKIE RD. | HIGHLAND PARK | IL | 60035 |
| K052668 | OR SPECIFIC, INC. |
4651 36TH ST. #500 | ORLANDO | FL | 32811 |
| K021864 | PRIMELINE MEDICAL PRODUCTS, INC. |
10707 100TH AVE., SUITE 300 | EDMONTON, ALBERTA | T5J 3M1 | |
| K022868 | PRIMELINE MEDICAL PRODUCTS, INC. |
10707-100TH AVE., SUITE 300 | EDMONTON, ALBERTA | T5J 3M1 | |
| K023117 | PRIMELINE MEDICAL PRODUCTS, INC. |
10707 100TH AVE., SUITE 300 | EDMONTON, ALBERTA | T5J 3M1 | |
| K042131 | PROMEDICAL PRODUCTS CO., LTD. |
125 CLEMENTS AVE. | STARKVILLE | MS | 39759 |
| K080629 | PROMEDICAL PRODUCTS CO., LTD. |
# 206 HAUNG HE ROAD WEST | CHANGZHOU, JIANGSU | 213022 | |
| K042137 | PROMEDICAL PRODUCTS CO., LTD. |
125 CLEMENTS AVE. | STARKVILLE | MS | 39759 |
| K970891 | PROTEK MEDICAL PRODUCTS, INC. |
221 E. MARKET ST. SUITE 291 | IOWA CITY | IA | 52245 |
| K970889 | PROTEK MEDICAL PRODUCTS, INC. |
221 E. MARKET ST. SUITE 291 | IOWA CITY | IA | 52245 |
| K101350 | RADSCAN MEDICAL EQUIPMENT, INC. |
23910 N. 19TH AVE BLDG 2 SUITE | PHOENIX | AZ | 85085 |
| K960803 | RX TEXTILES, INC. |
3107 CHAMBER DR. | MONROE | NC | 28110 |
| K080796 | SRI/SURGICAL EXPRESS |
P.O. BOX 92493 | AUSTIN | TX | 78709 |
| K012807 | STANDARD TEXTILE CO., INC. |
ONE KNOLLCREST DR. | CINCINNATI | OH | 45237-1600 |
| K980183 | STANDARD TEXTILE CO., INC. |
ONE KNOLLCREST DR. | CINCINNATI | OH | 45237-1600 |
| K081476 | SURGICAL CONCEPT DESIGNS |
307 PROSPECT AVENUE | HACKENSACK | NJ | 07601 |
| K091343 | SURGIVISION, INC. |
11874 SOUTH EVELYN CIRCLE | HOUSTON | TX | 77071 |
| K962003 | TAUT, INC. |
2571 KANEVILLE COURT | GENEVA | IL | 60134 |
| K960045 | THE SEWING SOURCE, INC. |
802 EAST NASH ST. | SPRING HOPE | NC | 27882 |
| K970722 | TRINITY LABORATORIES, INC. |
201 KILEY DR. | SALISBURY | MD | 21802 |
| K052395 | VOLCANO CORPORATION |
2870 KILGORE RD. | RANCHO CORDOVA | CA | 95670 |
| K070406 | VORTEK SURGICAL, LLC |
1426 W. 29TH ST. SUITE 300 | INDIANAPOLIS | IN | 46208 |
| K080341 | VORTEK SURGICAL, LLC |
1426 W. 29TH ST. SUITE 300 | INDIANAPOLIS | IN | 46208 |
| K141324 | WEIHAI HONGYU NONWOVEN FABRIC PRODUCTS CO., LTD |
P.O. BOX 120-119 | SHANGHAI | 200120 | |
| K070432 | WELMED INC. |
1340 WEST PENNSYLVANIA AVENUE | SAN DIEGO | CA | 92103 |
| K141438 | WHITNEY MEDICAL SOLUTIONS |
6153C WEST MULFORD STREET | NILES | IL | 60714 |
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