Clearance Summary
SUTURE RACK & NEEDLE COUNTER received FDA 510(k) clearance under submission number K760428, sponsored by Kleen Test Products. 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 1976-11-02.
- Submission: K760428
- Applicant / Sponsor: Kleen Test Products
- Clearance pathway: Traditional
- Review panel: General, Plastic Surgery
- Device class: Class I
- Regulation citation: 21 CFR 878.4800
- Decision date: 1976-11-02
Classification & Regulation
This clearance is catalogued under FDA product code FSM and 21 CFR 878.4800, within the General, Plastic Surgery review panel as a Class I device.