Clearance Summary
DENVER PARACENTESIS NEEDLE(60-1200) DENVER PARACENTESIS NEEDLE WITH DRAINAGE LINE(60-1100) DENVER PARACENTESIS TRAY received FDA 510(k) clearance under submission number K960456, sponsored by Denver Biomaterials, 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 1996-04-01.
- Submission: K960456
- Applicant / Sponsor: Denver Biomaterials, Inc.
- Clearance pathway: Traditional
- Review panel: General, Plastic Surgery
- Device class: Class I
- Regulation citation: 21 CFR 878.4800
- Decision date: 1996-04-01
Classification & Regulation
This clearance is catalogued under FDA product code KDD and 21 CFR 878.4800, within the General, Plastic Surgery review panel as a Class I device.