The following data is part of a premarket notification filed by Cox-uphuff Intl. with the FDA for Breast Prosthesis (non & Inflatable) Skin Expander.
| Device ID | K865033 |
| 510k Number | K865033 |
| Device Name: | BREAST PROSTHESIS (NON & INFLATABLE) SKIN EXPANDER |
| Classification | Expander, Skin, Inflatable |
| Applicant | COX-UPHUFF INTL. 1160 MARK AVE. Carpinteria, CA 93013 |
| Contact | David J Schuessler |
| Correspondent | David J Schuessler COX-UPHUFF INTL. 1160 MARK AVE. Carpinteria, CA 93013 |
| Product Code | LCJ |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-12-23 |
| Decision Date | 1987-01-12 |