Clearance Summary
CODMAN SUCTION PUNCH-PRODUCT CODES received FDA 510(k) clearance under submission number K842774, sponsored by Codman & Shurtleff, 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 1984-07-27.
- Submission: K842774
- Applicant / Sponsor: Codman & Shurtleff, Inc.
- Clearance pathway: Traditional
- Review panel: General, Plastic Surgery
- Device class: Class I
- Regulation citation: 21 CFR 878.4800
- Decision date: 1984-07-27
Classification & Regulation
This clearance is catalogued under FDA product code HTZ and 21 CFR 878.4800, within the General, Plastic Surgery review panel as a Class I device.