510(k) K051084

DENVER PLEURX DRAINAGE KIT AND DENVER PLEURX VACUUM BOTTLE WITH DRAINAGE LINE by Denver Biomedicals, Inc. — Product Code DWM

K051084 is an FDA 510(k) premarket notification submitted by Denver Biomedicals, Inc. for the device "DENVER PLEURX DRAINAGE KIT AND DENVER PLEURX VACUUM BOTTLE WITH DRAINAGE LINE". The FDA issued a decision of Substantially Equivalent on June 13, 2005. The device falls under product code DWM (Apparatus, Suction, Patient Care), a Class II device regulated under 21 CFR 870.5050. Denver Biomedicals, Inc. has at least 9 other 510(k) clearances on record.