Clearance Summary
RESTORELLE POLYPROPYLENE MESH; RESTORELLE POLYPROPYLENE MESH received FDA 510(k) clearance under submission number K103568, sponsored by Coloplast A/S. The device was reviewed via the Special premarket notification pathway and assigned to the General, Plastic Surgery review panel. The statutory decision date of record is 2010-12-22.
- Submission: K103568
- Applicant / Sponsor: Coloplast A/S
- Clearance pathway: Special
- Review panel: General, Plastic Surgery
- Device class: Class II
- Regulation citation: 21 CFR 878.3300
- Decision date: 2010-12-22
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.