Clearance Summary
SRI LP DRAPE received FDA 510(k) clearance under submission number K080796, sponsored by Sri/Surgical Express. 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 2008-11-17.
- Submission: K080796
- Applicant / Sponsor: Sri/Surgical Express
- Clearance pathway: Abbreviated
- Review panel: General, Plastic Surgery
- Device class: Class II
- Regulation citation: 21 CFR 878.4370
- Decision date: 2008-11-17
Classification & Regulation
This clearance is catalogued under FDA product code KKX and 21 CFR 878.4370, within the General, Plastic Surgery review panel as a Class II device.