Clearance Summary
HOOD & BEARD COVER, CLARION SURGEON'S received FDA 510(k) clearance under submission number K770257, sponsored by Sherwood Medical Industries. 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 1977-02-25.
- Submission: K770257
- Applicant / Sponsor: Sherwood Medical Industries
- Clearance pathway: Traditional
- Review panel: General, Plastic Surgery
- Device class: Class II
- Regulation citation: 21 CFR 878.4040
- Decision date: 1977-02-25
Classification & Regulation
This clearance is catalogued under FDA product code FXY and 21 CFR 878.4040, within the General, Plastic Surgery review panel as a Class II device.