Clearance Summary
VITAMESH MACROPOROUS PP SURGICAL MESH received FDA 510(k) clearance under submission number K060520, sponsored by Proxy Biomedical , Ltd.. The device was reviewed via the Abbreviated premarket notification pathway and assigned to the General, Plastic Surgery review panel. The statutory decision date of record is 2006-03-28.
- Submission: K060520
- Applicant / Sponsor: Proxy Biomedical , Ltd.
- Clearance pathway: Abbreviated
- Review panel: General, Plastic Surgery
- Device class: Class II
- Regulation citation: 21 CFR 878.3300
- Decision date: 2006-03-28
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.