Clearance Summary
SURGICAL GOWNS received FDA 510(k) clearance under submission number K890474, sponsored by Victoria Slipper Retail & Mfg., Co.. 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 1989-02-23.
- Submission: K890474
- Applicant / Sponsor: Victoria Slipper Retail & Mfg., Co.
- Clearance pathway: Traditional
- Review panel: General, Plastic Surgery
- Device class: Class II
- Regulation citation: 21 CFR 878.4040
- Decision date: 1989-02-23
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.