FDA 510(k) Applications for Medical Device:
Lubricant, Patient
| FDA 510(k) Number |
Applicant |
Address |
City / Country |
State / Province |
Postal Code |
| K083189 |
AVAIL MEDICAL PRODUCTS, INC. |
1900 CARNEGIE AVE.
| SANTA ANA |
CA |
92705 |
| K020586 |
BIOFILM, INC. |
3121 SCOTT ST.
| VISTA |
CA |
92083 |
| K041060 |
CHESTER LABS, INC. |
1900 SECTION RD.
| CINCINNATI |
OH |
45237 |
| K113689 |
DUKAL CORPORATION |
2 FLEETWOOD CT
| RONKONKOMA |
NY |
11779 |
| K092488 |
DYNAREX CORPORATION |
10 GLENSHAW ST.
| ORANGEBURG |
NY |
10962 |
| K112110 |
JIANERKANG MEDICAL DRESSING COMPANY |
ZHIXI TOWN
| JINTAN CITY, JIANGSU |
|
213251 |
| K103718 |
MEDLINE INDUSTRIES, INC. |
ONE MEDLINE PLACE
| MUNDELEIN |
IL |
60060 |
| K974768 |
NICE-PAK PRODUCTS, INC. |
TWO NICE-PAK PARK
| ORANGEBURG |
NY |
10962-1376 |
| K121390 |
NURSE ASSIST, INC. |
4409 Haltom Rd
| Haltom City |
TX |
76117 |
| K141028 |
PEDIATRIC PHARMACEUTICALS INC. |
2137 ROUTE 35
| HOLMDEL |
NJ |
07733 |
| K131617 |
PEDIATRIC PHARMACEUTICALS, INC. |
2137 ROUTE 35
| HOLMDEL |
NJ |
07733 |
| K961222 |
PHARMACEUTICAL INNOVATIONS, INC. |
1575 EYE STREET, N.W.
| WASHINGTON |
DC |
20005 |
| K973557 |
QUALIS, INC. |
4600 PARK AVE.
| DES MOINES |
IA |
50321 |
| K073684 |
SHEFFIELD INDUSTRIES, DIV. OF FARIA LTD. |
170 BROAD ST.
| NEW LONDON |
CT |
06320 |
| K142473 |
SION BIOTEXT MEDICAL LTD |
KIBBUTZ HAGOSHRIM
| UPPER GALILEE |
|
12225 |
| K961502 |
SPAN-AMERICA MEDICAL SYSTEMS, INC. |
70 COMMERCE DR.
| GREENVILLE |
SC |
29615 |
| K080042 |
SPIRUS MEDICAL, INC. |
5 WHITCOMB AVENUE
| AYER |
MA |
01432 |
| K042563 |
SSL AMERICAS, INC. |
3585 ENGINEERING DR.
| NORCROSS |
GA |
30092 |
| K101522 |
ULTRA SEAL CORPORATION |
521 MAIN STREET
| NEW PALTZ |
NY |
12561 |
|
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