Clearance Summary
SELF-CENTERING BONE HOLDING FORCEPS, 10-1/4 SS420 received FDA 510(k) clearance under submission number K853015, sponsored by The Huxley Instrument Corp.. 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 1985-07-29.
- Submission: K853015
- Applicant / Sponsor: The Huxley Instrument Corp.
- Clearance pathway: Traditional
- Review panel: General, Plastic Surgery
- Device class: Class I
- Regulation citation: 21 CFR 878.4800
- Decision date: 1985-07-29
Classification & Regulation
This clearance is catalogued under FDA product code GEN and 21 CFR 878.4800, within the General, Plastic Surgery review panel as a Class I device.