Clearance Summary
SEPRAMESH IP BIORESORBABLE COATING/PERMANENT MESH received FDA 510(k) clearance under submission number K053066, sponsored by Genzyme Corporation. 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 2005-12-19.
- Submission: K053066
- Applicant / Sponsor: Genzyme Corporation
- Clearance pathway: Traditional
- Review panel: General, Plastic Surgery
- Device class: Class II
- Regulation citation: 21 CFR 878.3300
- Decision date: 2005-12-19
Classification & Regulation
This clearance is catalogued under FDA product code FTL and 21 CFR 878.3300, within the General, Plastic Surgery review panel as a Class II device.