510(k) K912563

ANGEL WING SAFETY BLOOD COLLECTION AND INFUSION SE by Mbo Laboratories, Inc. — Product Code FOZ

K912563 is an FDA 510(k) premarket notification submitted by Mbo Laboratories, Inc. for the device "ANGEL WING SAFETY BLOOD COLLECTION AND INFUSION SE". The FDA issued a decision of Substantially Equivalent on October 2, 1991. The device falls under product code FOZ (Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days), a Class II device regulated under 21 CFR 880.5200. Mbo Laboratories, Inc. has at least 2 other 510(k) clearances on record.