The following data is part of a premarket notification filed by Great Bay Medical Products, Inc. with the FDA for Cosmet.
| Device ID | K933465 |
| 510k Number | K933465 |
| Device Name: | COSMET |
| Classification | Prosthesis, Breast, External, Used With Adhesive |
| Applicant | GREAT BAY MEDICAL PRODUCTS, INC. 750 CENTRAL AVE., SUITE H Dover, NH 03820 -3434 |
| Contact | Melvin E Prostkoff |
| Correspondent | Melvin E Prostkoff GREAT BAY MEDICAL PRODUCTS, INC. 750 CENTRAL AVE., SUITE H Dover, NH 03820 -3434 |
| Product Code | KCZ |
| CFR Regulation Number | 878.3800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-07-16 |
| Decision Date | 1994-07-20 |