Clearance Summary
SRI PLR GOWN received FDA 510(k) clearance under submission number K080707, 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 2008-11-13.
- Submission: K080707
- Applicant / Sponsor: Sri/Surgical Express
- Clearance pathway: Abbreviated
- Review panel: General, Plastic Surgery
- Device class: Class II
- Regulation citation: 21 CFR 878.4040
- Decision date: 2008-11-13
Classification & Regulation
This clearance is catalogued under FDA product code FYA and 21 CFR 878.4040, within the General, Plastic Surgery review panel as a Class II device.