Clearance Summary
ZARA ZONE IV MALAR IMPLANT received FDA 510(k) clearance under submission number K914016, sponsored by Byron Medical. The device was reviewed via the Traditional premarket notification pathway and assigned to the General, Plastic Surgery review panel. The statutory decision date of record is 1991-12-05.
- Submission: K914016
- Applicant / Sponsor: Byron Medical
- Clearance pathway: Traditional
- Review panel: General, Plastic Surgery
- Device class: Class II
- Regulation citation: 21 CFR 878.3550
- Decision date: 1991-12-05
Classification & Regulation
This clearance is catalogued under FDA product code LZK and 21 CFR 878.3550, within the General, Plastic Surgery review panel as a Class II device.