Clearance Summary
STERILE DISPOSABLE PN DRAPE SYSTEM received FDA 510(k) clearance under submission number K850912, sponsored by Brant-Wald Surgicals, 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 1985-05-03.
- Submission: K850912
- Applicant / Sponsor: Brant-Wald Surgicals, Inc.
- Clearance pathway: Traditional
- Review panel: General, Plastic Surgery
- Device class: Class II
- Regulation citation: 21 CFR 878.4370
- Decision date: 1985-05-03
Classification & Regulation
This clearance is catalogued under FDA product code KKX and 21 CFR 878.4370, within the General, Plastic Surgery review panel as a Class II device.