Clearance Summary
POLY-MED DISP. PERS. PROT. GOWN APRON & SHOECOVERS received FDA 510(k) clearance under submission number K925077, sponsored by Medtek Development Corp.. 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 1993-08-16.
- Submission: K925077
- Applicant / Sponsor: Medtek Development Corp.
- Clearance pathway: Traditional
- Review panel: General, Plastic Surgery
- Device class: Class II
- Regulation citation: 21 CFR 878.4040
- Decision date: 1993-08-16
Classification & Regulation
This clearance is catalogued under FDA product code FYC and 21 CFR 878.4040, within the General, Plastic Surgery review panel as a Class II device.