| Device Classification Name |
Gauze/Sponge, Internal
|
| 510(k) Number |
K874067 |
| Device Name |
GUAZE SPONGES |
| Applicant |
| Interpro Intl., Inc. |
| 2 Viewpoint Ter. |
|
Lebanon,
NJ
08833
|
|
| Applicant Contact |
WAYNE R KNUPP |
| Correspondent |
| Interpro Intl., Inc. |
| 2 Viewpoint Ter. |
|
Lebanon,
NJ
08833
|
|
| Correspondent Contact |
WAYNE R KNUPP |
| Classification Product Code |
|
| Date Received | 10/05/1987 |
| Decision Date | 12/14/1987 |
| 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
|
|
|