Clearance Summary
TIBURON DRAPE, MODEL 9349N/ OPTIMA DRAPE, MODEL 9446N received FDA 510(k) clearance under submission number K061762, sponsored by Cardinal Health, Inc.. The device was reviewed via the Special premarket notification pathway and assigned to the General, Plastic Surgery review panel. The statutory decision date of record is 2006-08-01.
- Submission: K061762
- Applicant / Sponsor: Cardinal Health, Inc.
- Clearance pathway: Special
- Review panel: General, Plastic Surgery
- Device class: Class II
- Regulation citation: 21 CFR 878.4370
- Decision date: 2006-08-01
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.