Clearance Summary
COM-MED O.R. TOWEL - NON-STERILE, BLUE, GREEN, WHITE received FDA 510(k) clearance under submission number K002691, sponsored by Com-Med International, 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 2000-12-08.
- Submission: K002691
- Applicant / Sponsor: Com-Med International, Inc.
- Clearance pathway: Traditional
- Review panel: General, Plastic Surgery
- Device class: Class II
- Regulation citation: 21 CFR 878.4370
- Decision date: 2000-12-08
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.