Clearance Summary
BODY BOOT received FDA 510(k) clearance under submission number K940723, sponsored by Mark-Clark. 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 1994-09-06.
- Submission: K940723
- Applicant / Sponsor: Mark-Clark
- Clearance pathway: Traditional
- Review panel: General, Plastic Surgery
- Device class: Class I
- Regulation citation: 21 CFR 878.4040
- Decision date: 1994-09-06
Classification & Regulation
This clearance is catalogued under FDA product code LYU and 21 CFR 878.4040, within the General, Plastic Surgery review panel as a Class I device.