| Device Classification Name |
Gauze/Sponge, Internal
|
| 510(k) Number |
K910623 |
| Device Name |
GAUZE SPONGES ABSORBENT GAUZE ROLLS |
| Applicant |
| Liaoning-Usa Corp. |
| 123 W. Bellevue, Unit#4 |
|
Pasadena,
CA
91105
|
|
| Applicant Contact |
JAY A BROWN |
| Correspondent |
| Liaoning-Usa Corp. |
| 123 W. Bellevue, Unit#4 |
|
Pasadena,
CA
91105
|
|
| Correspondent Contact |
JAY A BROWN |
| Classification Product Code |
|
| Date Received | 02/13/1991 |
| Decision Date | 04/01/1991 |
| Decision |
Substantially Equivalent
(SESE) |
| 510k Review Panel |
General & Plastic Surgery
|
| Type |
Traditional
|
| Reviewed by Third Party |
No
|
| Combination Product |
No
|
Predetermined Change Control Plan Authorized |
No
|
|
|