FDA 510(k) Applications for Medical Device:
Valve, Non-Rebreathing
| FDA 510(k) Number | Applicant | Address | City / Country | State / Province | Postal Code |
|---|---|---|---|---|---|
| K142402 | 12th Man Technologies, Inc. |
7245 Garden Grove Blvd., Suite C | Garden Grove | CA | 92841 |
| K031431 | BAWMED UK |
6 GREAT HOUSE MEADOWS | UNITED KINGDOM | CF61 ISU. | |
| K955634 | BOSTON MEDICAL PRODUCTS, INC. |
117 FLANDERS RD. | WESTBOROUGH | MA | 01581 |
| K082345 | BPR MEDICAL, LTD. |
22, HAMILTON WAY | MANSFIELD, NOTTINGHAMSHIRE | NG18 5BU | |
| K954426 | CAREFREE TRADING, INC. |
14602 NORTH CAVE CREEK RD., | PHOENIX | AZ | 85022 |
| K960587 | CERTIFIED SAFETY MFG., INC. |
1400 CHESTNUT | KANSAS CITY | MO | 64127 |
| K010191 | CHEEN HOUNG ENT. CO. LTD. |
23 SAN DREEN ST., ALLEY 11, | TAIPEI (SHULIN) | 23805 | |
| K052743 | DYNAREX CORP. |
10 GLENSHAW ST. | ORANGEBURG | NY | 10962 |
| K980052 | EMERGENCY FILTRATION PRODUCTS, INC. |
321 NORTH MALL DR. | ST. GEORGE | UT | 84790 |
| K983919 | ENGINEERED MEDICAL SYSTEMS |
8529 ZIONSVILLE RD. | INDIANAPOLIS | IN | 46268 |
| K083418 | FIRSTAR HEALTHCARE CO., LTD. |
3500 SOUTH DUPONT HIGHWAY | DOVER | DE | 19901 |
| K192285 | Firstar Healthcare Company Limited (Guangzhou) |
Rm.901, Building No.2,Headquarters Center, | Guangzhou | 511400 | |
| K173770 | Fisher & Paykel Healthcare Limited |
15 Maurice Paykel Place, | Auckland | 2013 | |
| K040366 | FISHER & PAYKEL HEALTHCARE, LTD. |
15 MAURICE PAYKEL PLACE | EAST TAMAKI | ||
| K042727 | FOREMOUNT ENT. CO., LTD. |
9F-4, NO.1 LANE 641 | TA YA HSIANG, TAICHUNG | 428 | |
| K953230 | FORMOSA-CJ HEALTH BUSINESS CORP. |
6329 W. WATERVIEW CT. | MCCORDSVILLE | IN | 46055-9501 |
| K102299 | GENUINE FIRST AID LLC |
150 CHERRY LANE RD. | EAST STROUDSBURG | PA | 18301 |
| K112126 | GENUINE FIRST AID LLC |
150 CHERRY LANE RD. | EAST STROUDSBURG | PA | 18301 |
| K142764 | HANGZHOU JINLIN MEDICAL APPLIANCES CO., LTD. |
No. 9 16TH AVE HANGZHOU ECONOMIC & | HANGZHOU | 310018 | |
| K983631 | INSTRUMENTATION INDUSTRIES, INC. |
2990 INDUSTRIAL BLVD. | BETHEL PARK | PA | 15102 |
| K980725 | INSTRUMENTATION INDUSTRIES, INC. |
2990 INDUSTRIAL BLVD. | BETHEL PARK | PA | 15102 |
| K973066 | INSTRUMENTATION INDUSTRIES, INC. |
2990 INDUSTRIAL BLVD. | BETHEL PARK | PA | 15102 |
| K970780 | INSTRUMENTATION INDUSTRIES, INC. |
2990 INDUSTRIAL BLVD. | BETHEL PARK | PA | 15102 |
| K955520 | INTERNATIONAL SAFETY, INC. |
2322 DOUGLAS DR. | EUGENE | OR | 97405 |
| K132143 | INTERSURGICAL INCORPORATED |
417 ELECTRONICS PARKWAY | LIVERPOOL | NY | 13088 |
| K984481 | INTERSURGICAL, INC. |
417 ELECTRONICS PKWY. | LIVERPOOL | NY | 13088 |
| K023805 | LAERDAL MEDICAL A/S |
TANKE SVILANDSGATE 30 | STAVANGER | 4002 | |
| K001742 | LAERDAL MEDICAL CORP. |
49 PLAIN ST. | NORTH ATTLEBORO | MA | 02760 |
| K052458 | LIV MEDICA PRODUCTS PVT. LTD. |
458 BRIARCREEK DRIVE | HOCKESSIN | DE | 19707 |
| K210992 | Meditera Tibbi Malzeme San Ve TIC AS |
Ibni Melek OSB Mah, TOSHI Yol 4 Sol. No. 29 Tire | Tire Izmir | 35900 | |
| K081516 | MEDSOURCE INTERNATIONAL, LLC. |
5346 SHORELINE DR. | MOUND | MN | 55364 |
| K031397 | MERLIN MEDICAL LIMITED |
THE WHITBREAD CENTRE,RHYMNEY, | UNITED KINGDOM | NP22 5BF | |
| K960995 | O-TWO SYSTEMS INTL., INC. |
7575 KIMBEL ST., UNIT 5 | ONTARIO L5S 1C8 | ||
| K953414 | PLASCO, INC. |
4080 MORRISON DR. | GURNEE | IL | 60031 |
| K981169 | RONDEX PRODUCTS, INC. |
P.O. BOX NO. 1829 | ROCKFORD | IL | 61110 |
| K993528 | RUSCH, INC. |
2450 MEADOWBROOK PKWY. | DULUTH | GA | 30096 |
| K953461 | SAFETEC OF AMERICA, INC. |
1055 EAST DELAVAN AVE. | BUFFALO | NY | 14215 |
| K030943 | SENSOR MEDICS CORP. |
22705 SAVI RANCH PKWY. | YORBA LINDA | CA | 92887 |
| K020665 | SENSORMEDICS CORP. |
22705 SAVI RANCH PKWY. | YORBA LINDA | CA | 92887-4645 |
| K963755 | SPIRACLE TECHNOLOGY |
16912 VON KARMAN AVE. | IRVINE | CA | 92606-4923 |
| K953349 | SPIRACLE TECHNOLOGY |
16912 VON KARMAN AVE. | IRVINE | CA | 92606-4923 |
| K152521 | The Lifeguard Store, Inc. |
2012 W. College Ave. | Normal | IL | 61761 |
| K111191 | WET NOSE TECHNOLOGIES, LLC |
3750 2ND AVE | LOS ANGELES | CA | 90018 |
| K091538 | WET NOSE TECHNOLOGIES, LLC |
3750 2ND AVE | LOS ANGELES | CA | 90018 |
| K991617 | WHITELINE PLASTICS, INC. |
6800 COLUMBUS ROAD | MISSISSAUGA, ONTARIO | L5T 2G1 | |
| K171961 | Xiamen Compower Medical Tech. Co. Ltd. |
Unit 301, No.16 Xianghong Road, Xiang'an Torch | Xiamen | 361101 |
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