Clearance Summary
CEMENT-PICK received FDA 510(k) clearance under submission number K822108, sponsored by Bio-Blitz, 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 1982-08-11.
- Submission: K822108
- Applicant / Sponsor: Bio-Blitz, Inc.
- Clearance pathway: Traditional
- Review panel: General, Plastic Surgery
- Device class: Class I
- Regulation citation: 21 CFR 878.4800
- Decision date: 1982-08-11
Classification & Regulation
This clearance is catalogued under FDA product code GAF and 21 CFR 878.4800, within the General, Plastic Surgery review panel as a Class I device.