Clearance Summary
ZANLEX, ZAN-TEX & ZANDEX received FDA 510(k) clearance under submission number K830511, sponsored by Winn Hirsch & Assoc.. 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 1983-03-17.
- Submission: K830511
- Applicant / Sponsor: Winn Hirsch & Assoc.
- Clearance pathway: Traditional
- Review panel: General, Plastic Surgery
- Device class: Class I
- Regulation citation: 21 CFR 878.4450
- Decision date: 1983-03-17
Classification & Regulation
This clearance is catalogued under FDA product code GDY and 21 CFR 878.4450, within the General, Plastic Surgery review panel as a Class I device.