Clearance Summary
SUTRAZORB received FDA 510(k) clearance under submission number K102592, sponsored by Visionary Medical Supplies, Inc.. 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 2011-02-03.
- Submission: K102592
- Applicant / Sponsor: Visionary Medical Supplies, Inc.
- Clearance pathway: Abbreviated
- Review panel: General, Plastic Surgery
- Device class: Class II
- Regulation citation: 21 CFR 878.4493
- Decision date: 2011-02-03
Classification & Regulation
This clearance is catalogued under FDA product code GAM and 21 CFR 878.4493, within the General, Plastic Surgery review panel as a Class II device.