The following data is part of a premarket notification filed by Byron Medical with the FDA for Zara Zone Iv Malar Implant Modification.
| Device ID | K934233 |
| 510k Number | K934233 |
| Device Name: | ZARA ZONE IV MALAR IMPLANT MODIFICATION |
| Classification | Implant, Malar |
| Applicant | BYRON MEDICAL 3280 E. HEMISPHERE LOOP SUITE 100 Tucson, AZ 85706 |
| Contact | Byron Economidy |
| Correspondent | Byron Economidy BYRON MEDICAL 3280 E. HEMISPHERE LOOP SUITE 100 Tucson, AZ 85706 |
| Product Code | LZK |
| CFR Regulation Number | 878.3550 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-08-30 |
| Decision Date | 1994-02-03 |