Clearance Summary
TULIP DISPOSABLE CANNULAS received FDA 510(k) clearance under submission number K060089, sponsored by Cell Bio-Systems, 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 2006-04-27.
- Submission: K060089
- Applicant / Sponsor: Cell Bio-Systems, Inc.
- Clearance pathway: Traditional
- Review panel: General, Plastic Surgery
- Device class: Class II
- Regulation citation: 21 CFR 878.5040
- Decision date: 2006-04-27
Classification & Regulation
This clearance is catalogued under FDA product code QPB and 21 CFR 878.5040, within the General, Plastic Surgery review panel as a Class II device.