The following data is part of a premarket notification filed by Cox-uphuff Intl. with the FDA for Cui Rhinoplasty Implants.
| Device ID | K853945 |
| 510k Number | K853945 |
| Device Name: | CUI RHINOPLASTY IMPLANTS |
| Classification | Prosthesis, Nose, Internal |
| Applicant | COX-UPHUFF INTL. 725 E. YANONALI ST. Santa Barbara, CA 93103 |
| Contact | David J Schuessler |
| Correspondent | David J Schuessler COX-UPHUFF INTL. 725 E. YANONALI ST. Santa Barbara, CA 93103 |
| Product Code | FZE |
| CFR Regulation Number | 878.3680 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-09-24 |
| Decision Date | 1985-10-18 |