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 |