Clearance Summary
DRAPE, SURGICAL received FDA 510(k) clearance under submission number K820078, sponsored by James L. Geraci & Associates, 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 1982-02-04.
- Submission: K820078
- Applicant / Sponsor: James L. Geraci & Associates, Inc.
- Clearance pathway: Traditional
- Review panel: General, Plastic Surgery
- Device class: Class II
- Regulation citation: 21 CFR 878.4370
- Decision date: 1982-02-04
Classification & Regulation
This clearance is catalogued under FDA product code KKX and 21 CFR 878.4370, within the General, Plastic Surgery review panel as a Class II device.