Clearance Summary
C ARM SURGICAL TABLE received FDA 510(k) clearance under submission number K860446, sponsored by Medi-Mech, Inc.. 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 1986-03-10.
- Submission: K860446
- Applicant / Sponsor: Medi-Mech, Inc.
- Clearance pathway: Traditional
- Review panel: General, Plastic Surgery
- Device class: Class I
- Regulation citation: 21 CFR 878.4950
- Decision date: 1986-03-10
Classification & Regulation
This clearance is catalogued under FDA product code FWZ and 21 CFR 878.4950, within the General, Plastic Surgery review panel as a Class I device.