Clearance Summary
RESTORELLE Y CONTOUR MESH received FDA 510(k) clearance under submission number K140116, 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 2014-02-12.
- Submission: K140116
- 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: 2014-02-12
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.