Clearance Summary
SKYTRON ELITE 300 SURGERY TABLE received FDA 510(k) clearance under submission number K853479, sponsored by Skytron, Div. the Kmw Group, 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 1985-09-05.
- Submission: K853479
- Applicant / Sponsor: Skytron, Div. the Kmw Group, Inc.
- Clearance pathway: Traditional
- Review panel: General, Plastic Surgery
- Device class: Class I
- Regulation citation: 21 CFR 878.4960
- Decision date: 1985-09-05
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.