510(k) K052843

BUSSE HOSPITAL DISPOSABLES NEEDLE STICK BLOCK/CUBE by Busse Hospital Disposables, Inc. — Product Code FMI

K052843 is an FDA 510(k) premarket notification submitted by Busse Hospital Disposables, Inc. for the device "BUSSE HOSPITAL DISPOSABLES NEEDLE STICK BLOCK/CUBE". The FDA issued a decision of Substantially Equivalent on April 17, 2006. The device falls under product code FMI (Needle, Hypodermic, Single Lumen), a Class II device regulated under 21 CFR 880.5570. Busse Hospital Disposables, Inc. has at least 10 other 510(k) clearances on record.