Clearance Summary
CAPTAIN'S CHAIR ACCESSORY TO AMSCO SURGICAL TABLES received FDA 510(k) clearance under submission number K935356, sponsored by Amsco American Sterilizer Co.. 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 1994-03-23.
- Submission: K935356
- Applicant / Sponsor: Amsco American Sterilizer Co.
- Clearance pathway: Traditional
- Review panel: General, Plastic Surgery
- Device class: Class I
- Regulation citation: 21 CFR 878.4960
- Decision date: 1994-03-23
Classification & Regulation
This clearance is catalogued under FDA product code FWW and 21 CFR 878.4960, within the General, Plastic Surgery review panel as a Class I device.