Clearance Summary
SRI LEVEL II SURGICAL GOWN received FDA 510(k) clearance under submission number K090383, sponsored by Sri Surgical. 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 2009-05-29.
- Submission: K090383
- Applicant / Sponsor: Sri Surgical
- Clearance pathway: Abbreviated
- Review panel: General, Plastic Surgery
- Device class: Class II
- Regulation citation: 21 CFR 878.4040
- Decision date: 2009-05-29
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.