FDA 510(k) Applications for Medical Device:
Respirator,Surgical
| FDA 510(k) Number | Applicant | Address | City / Country | State / Province | Postal Code |
|---|---|---|---|---|---|
| K063023 | 3M COMPANY |
3M CENTER BUILDING 275-05W-06 | ST. PAUL | MN | 55144 |
| K121069 | 3M COMPANY |
3M CENTER, BLDG. 275-5W-06 | ST. PAUL | MN | 55144-1000 |
| K171116 | 3M Health Care |
3M Center, 2510 Conway Ave., Building 275-5W-06 | St. Paul | MN | 55144 |
| K041855 | AEARO CO. |
90 MECHANIC ST. | SOUTHBRIDGE | MA | 01550 |
| K072359 | AEARO COMPANY |
90 MECHANIC ST. | SOUTHBRIDGE | MA | 01550 |
| K070168 | AEARO COMPANY |
90 MECHANIC ST. | SOUTHBRIDGE | MA | 01550 |
| K063013 | AEARO COMPANY |
90 MECHANIC ST. | SOUTHBRIDGE | MA | 01550 |
| K092824 | ALPHAPROTECH, INC. |
236 NORTH 2200 WEST | SALT LAKE CITY | UT | 84116 |
| K070692 | DUKAL CORPORATION |
5 PLANT AVENUE | HAUPPAUGE | NY | 11788 |
| K080827 | HANDAN HENGYONG PROTECTIVE & CLEAN PRODUCTS CO., L |
1-1-1201, 455 GONGNONG ROAD | SHIJIAZHUANG, HEBEI PROVINCE | 050051 | |
| K051182 | INOVEL LLC |
10111 W. JEFFERSON BLVD. | CULVER CITY | CA | 90232-3509 |
| K042267 | INOVEL LLC |
10111 W. JEFFERSON BLVD. | CULVER CITY | CA | 90232-3509 |
| K061859 | INOVEL LLC |
10111 W. JEFFERSON BLVD. | CULVER CITY | CA | 90232-3509 |
| K062665 | INOVEL LLC |
10111 W. JEFFERSON BLVD. | CULVER CITY | CA | 90232-3509 |
| K063747 | INOVEL LLC |
10111 W. JEFFERSON BLVD. | CULVER CITY | CA | 90232-3509 |
| K050193 | LOUIS M. GERSON CO., INC. |
15 SPROAT ST. | MIDDLEBORO | MA | 02346 |
| K960778 | LOUIS M. GERSON CO., INC. |
15 SPROAT ST. | MIDDLEBORO | MA | 02346 |
| K061375 | LOUIS M. GERSON CO., INC. |
15 SPROAT ST. | MIDDLEBORO | MA | 02346 |
| K020474 | MAKRITE INDUSTRIES, INC. |
24 TOWER ST. | WEBSTER | MA | 01570 |
| K172963 | Master & Frank Enterprise Co., Ltd |
Banhu Industrial District | Dong Duan | 523000 | |
| K062663 | MOLDEX/METRIC, INC. |
10111 WEST JEFFERSON BLVD. | CULVER CITY | CA | 90232 |
| K102173 | MOLDEX/METRIC, INC. |
10111 WEST JEFFERSON BLVD. | CULVER CITY | CA | 90232 |
| K102923 | MOLNLYCKE HEALTHCARE |
5550 PEACHTREE PARKWAY | NORCROSS | GA | 30092 |
| K233022 | Owens & Minor (O&M) Halyard, Inc. |
9120 Lockwood Blvd | Mechanicsville | VA | 23116 |
| K141876 | PASTURE PHARMA PTE LTD |
38129 SPRING CANYON DRIVE | MURRIETA | CA | 92563 |
| K102092 | Prestige Ameritech |
7201 Iron Horse Blvd | North Richland Hills | TX | 76180 |
| K100139 | SAFELIFE CORP. |
12250 EL CAMINO REAL | SAN DIEGO | CA | 92130 |
| K160271 | SAN-M PACKAGE CO., LTD. |
1086-1 OJIRO | SHIMADA-CITY | 428-8652 | |
| K090131 | SHANGHAI DASHENG HEALTH PRODUCTS |
SONGJIANG DISTRICT | SHANGHAI | ||
| K063334 | SHANGHAI GANGKAI PURIFYING PRODUCTS CO., LTD. |
7380 36TH COURT | VERO BEACH | FL | 32967 |
| K072067 | SHUENN BAO SHING CORPORATION |
NO. 58, FU CHIUN STREET | HSIN CHU CITY | 30067 | |
| K070782 | SURVIVAIR RESPIRATORS, LLC |
1025 W. EVERETT RD. | LAKE FOREST | IL | 60045 |
| K070139 | SURVIVAIR, INC. |
1025 W.EVERETT RD. | LAKE FOREST | IL | 60045 |
| K970448 | TECNOL MEDICAL PRODUCTS, INC. |
7201 INDUSTRIAL PARK BLVD. | FORT WORTH | TX | 76180 |
| K974068 | TECNOL MEDICAL PRODUCTS, INC. |
7201 INDUSTRIAL PARK BLVD. | FORT WORTH | TX | 76180 |
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