Clearance Summary
RESTORELLE M, RESTORELLE XL received FDA 510(k) clearance under submission number K132061, sponsored by Coloplast Corp.. 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 2013-08-02.
- Submission: K132061
- Applicant / Sponsor: Coloplast Corp.
- Clearance pathway: Special
- Review panel: General, Plastic Surgery
- Device class: Class II
- Regulation citation: 21 CFR 878.3300
- Decision date: 2013-08-02
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.