Clearance Summary
DISPOSABLE SURG KITS/GOWNS/GUARDS/COVERS/MASKS received FDA 510(k) clearance under submission number K861525, sponsored by D & D Products, 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 1986-05-06.
- Submission: K861525
- Applicant / Sponsor: D & D Products, Inc.
- Clearance pathway: Traditional
- Review panel: General, Plastic Surgery
- Device class: Class I
- Regulation citation: 21 CFR 878.4800
- Decision date: 1986-05-06
Classification & Regulation
This clearance is catalogued under FDA product code FSM and 21 CFR 878.4800, within the General, Plastic Surgery review panel as a Class I device.