Clearance Summary
SURGICAL APPAREL SHOE COVERS received FDA 510(k) clearance under submission number K831952, sponsored by Sudreca Surgical Dressings, Inc.. 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 1983-07-12.
- Submission: K831952
- Applicant / Sponsor: Sudreca Surgical Dressings, Inc.
- Clearance pathway: Traditional
- Review panel: General, Plastic Surgery
- Device class: Class I
- Regulation citation: 21 CFR 878.4040
- Decision date: 1983-07-12
Classification & Regulation
This clearance is catalogued under FDA product code BWP and 21 CFR 878.4040, within the General, Plastic Surgery review panel as a Class I device.