Clearance Summary
SURGICAL GOWN received FDA 510(k) clearance under submission number K912790, sponsored by Unicor Federal Dept. of Justice. The device was reviewed via the Traditional premarket notification pathway and assigned to the General, Plastic Surgery review panel. The statutory decision date of record is 1991-09-19.
- Submission: K912790
- Applicant / Sponsor: Unicor Federal Dept. of Justice
- Clearance pathway: Traditional
- Review panel: General, Plastic Surgery
- Device class: Class I
- Regulation citation: 21 CFR 878.4040
- Decision date: 1991-09-19
Classification & Regulation
This clearance is catalogued under FDA product code FYE and 21 CFR 878.4040, within the General, Plastic Surgery review panel as a Class I device.