Clearance Summary
SHAMPAINE 1000 SERIES ANGENIEUX AX-14 DUO,AX-4 received FDA 510(k) clearance under submission number K904965, sponsored by Smith & Nephew Equipment Group. 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 1991-01-16.
- Submission: K904965
- Applicant / Sponsor: Smith & Nephew Equipment Group
- Clearance pathway: Traditional
- Review panel: General, Plastic Surgery
- Device class: Class II
- Regulation citation: 21 CFR 878.4580
- Decision date: 1991-01-16
Classification & Regulation
This clearance is catalogued under FDA product code FSY and 21 CFR 878.4580, within the General, Plastic Surgery review panel as a Class II device.