510(k) K090156

ISOLYSER SHARPS ROOM SYSTEM, MODEL 800; ISOLYSER SHARPS MANAGEMENT SYSTEM, MODELS 2400, 4000, 10000 by Wcm Waste & Compliance Management, Inc. — Product Code FMI

K090156 is an FDA 510(k) premarket notification submitted by Wcm Waste & Compliance Management, Inc. for the device "ISOLYSER SHARPS ROOM SYSTEM, MODEL 800; ISOLYSER SHARPS MANAGEMENT SYSTEM, MODELS 2400, 4000, 10000". The FDA issued a decision of Substantially Equivalent on Sep 1, 2009. The device falls under product code FMI (Needle, Hypodermic, Single Lumen), a Class II device regulated under 21 CFR 880.5570. Wcm Waste & Compliance Management, Inc. has 1 other 510(k) clearance on record.