About This 510(k) Submission
K960456 is an FDA 510(k) clearance for the DENVER PARACENTESIS NEEDLE(60-1200) DENVER PARACENTESIS NEEDLE WITH DRAINAGE LINE(60-1100) DENVER PARACENTESIS TRAY, a Kit, Surgical Instrument, Disposable (Class I — General Controls, product code KDD), submitted by Denver Biomaterials, Inc. (Evergreen, US). The FDA issued a Cleared decision on April 1, 1996, 62 days after receiving the submission on January 30, 1996. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.4800.