Clearance Summary
POLYFORM SYNTHETIC MESH received FDA 510(k) clearance under submission number K051245, sponsored by Proxy Biomedical , Ltd.. 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 2005-06-17.
- Submission: K051245
- Applicant / Sponsor: Proxy Biomedical , Ltd.
- Clearance pathway: Traditional
- Review panel: General, Plastic Surgery
- Device class: Class II
- Regulation citation: 21 CFR 878.3300
- Decision date: 2005-06-17
Classification & Regulation
This clearance is catalogued under FDA product code OTO and 21 CFR 878.3300, within the General, Plastic Surgery review panel as a Class II device.