The following data is part of a premarket notification filed by Byron Medical with the FDA for Zara Soft Tip Chin Implant.
| Device ID | K910458 |
| 510k Number | K910458 |
| Device Name: | ZARA SOFT TIP CHIN IMPLANT |
| Classification | Prosthesis, Chin, Internal |
| Applicant | BYRON MEDICAL 3280 E. HEMISPHERE LOOP SUITE 100 Tucson, AZ 85706 |
| Contact | Byron G Economidy |
| Correspondent | Byron G Economidy BYRON MEDICAL 3280 E. HEMISPHERE LOOP SUITE 100 Tucson, AZ 85706 |
| Product Code | FWP |
| CFR Regulation Number | 878.3550 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-02-04 |
| Decision Date | 1991-02-19 |