Clearance Summary
NORSEN DEBRIDER received FDA 510(k) clearance under submission number K821801, sponsored by Bel-Med, 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 1982-07-28.
- Submission: K821801
- Applicant / Sponsor: Bel-Med, Inc.
- Clearance pathway: Traditional
- Review panel: General, Plastic Surgery
- Device class: Class I
- Regulation citation: 21 CFR 878.4800
- Decision date: 1982-07-28
Classification & Regulation
This clearance is catalogued under FDA product code GED and 21 CFR 878.4800, within the General, Plastic Surgery review panel as a Class I device.