The following data is part of a premarket notification filed by Almost U., Inc. with the FDA for Almost U, Inc. Breast Prosthesis.
| Device ID | K933668 |
| 510k Number | K933668 |
| Device Name: | ALMOST U, INC. BREAST PROSTHESIS |
| Classification | Prosthesis, Breast, External, Used With Adhesive |
| Applicant | ALMOST U., INC. 1006 BROWN ST. Peekskill, NY 10566 |
| Contact | Fred J Bianco, Jr. |
| Correspondent | Fred J Bianco, Jr. ALMOST U., INC. 1006 BROWN ST. Peekskill, NY 10566 |
| Product Code | KCZ |
| CFR Regulation Number | 878.3800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-07-28 |
| Decision Date | 1993-12-10 |