| Device Classification Name |
prosthesis, breast, external, used with adhesive
|
|---|
| 510(k) Number |
K933465 |
|---|
| Device Name |
COSMET |
|---|
| Applicant |
| GREAT BAY MEDICAL PRODUCTS, INC. |
| 750 CENTRAL AVE., SUITE H |
|
DOVER,
NH
03820 -3434
|
|
| Applicant Contact |
MELVIN E PROSTKOFF |
| Correspondent |
| GREAT BAY MEDICAL PRODUCTS, INC. |
| 750 CENTRAL AVE., SUITE H |
|
DOVER,
NH
03820 -3434
|
|
| Correspondent Contact |
MELVIN E PROSTKOFF |
| Regulation Number | 878.3800
|
|---|
| Classification Product Code |
|
|---|
| Date Received | 07/16/1993 |
|---|
| Decision Date | 07/20/1994 |
|---|
| Decision |
Substantially Equivalent
(SESE) |
|---|
| Regulation Medical Specialty |
General & Plastic Surgery
|
|---|
| 510k Review Panel |
General & Plastic Surgery
|
|---|
| Type |
Traditional
|
|---|
| Reviewed by Third Party |
No
|
|---|
| Combination Product |
No
|
|---|