510(k) K960456

DENVER PARACENTESIS NEEDLE(60-1200) DENVER PARACENTESIS NEEDLE WITH DRAINAGE LINE(60-1100) DENVER PARACENTESIS TRAY by Denver Biomaterials, Inc. — Product Code KDD

K960456 is an FDA 510(k) premarket notification submitted by Denver Biomaterials, Inc. for the device "DENVER PARACENTESIS NEEDLE(60-1200) DENVER PARACENTESIS NEEDLE WITH DRAINAGE LINE(60-1100) DENVER PARACENTESIS TRAY". The FDA issued a decision of Substantially Equivalent on April 1, 1996. The device falls under product code KDD (Kit, Surgical Instrument, Disposable), a Class I device regulated under 21 CFR 878.4800. Denver Biomaterials, Inc. has at least 3 other 510(k) clearances on record.