510(k) K011786

VACUETTE SAFETY BLOOD COLLECTION SET by Greiner Vacuette North America, Inc. — Product Code FMI

K011786 is an FDA 510(k) premarket notification submitted by Greiner Vacuette North America, Inc. for the device "VACUETTE SAFETY BLOOD COLLECTION SET". The FDA issued a decision of Substantially Equivalent on July 12, 2001. The device falls under product code FMI (Needle, Hypodermic, Single Lumen), a Class II device regulated under 21 CFR 880.5570. Greiner Vacuette North America, Inc. has at least 4 other 510(k) clearances on record.