Clearance Summary
HARD TISSUE REPLACEMENT (HTR) GRANULAR received FDA 510(k) clearance under submission number K934861, sponsored by Poly-Medics,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 1994-11-04.
- Submission: K934861
- Applicant / Sponsor: Poly-Medics,Inc.
- Clearance pathway: Traditional
- Review panel: General, Plastic Surgery
- Device class: Class II
- Regulation citation: 21 CFR 878.3500
- Decision date: 1994-11-04
Classification & Regulation
This clearance is catalogued under FDA product code KKY and 21 CFR 878.3500, within the General, Plastic Surgery review panel as a Class II device.