| Device Classification Name |
Dressing, Wound And Burn, Occlusive
|
| 510(k) Number |
K930401 |
| Device Name |
ALUMINUM FOIL |
| Applicant |
| Gam Industries, Inc. |
| P.O. Box 2226 |
|
Petersburg,
VA
23804
|
|
| Applicant Contact |
GARY J BEDEN |
| Correspondent |
| Gam Industries, Inc. |
| P.O. Box 2226 |
|
Petersburg,
VA
23804
|
|
| Correspondent Contact |
GARY J BEDEN |
| Classification Product Code |
|
| Date Received | 01/26/1993 |
| Decision Date | 05/12/1993 |
| 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
|
|
|