510(k) K911732

ADVANCE DISPOSABLE CONTROL SYRINGE by Advance Medical Designs, Inc. — Product Code IZI

K911732 is an FDA 510(k) premarket notification submitted by Advance Medical Designs, Inc. for the device "ADVANCE DISPOSABLE CONTROL SYRINGE". The FDA issued a decision of Substantially Equivalent on September 16, 1991. The device falls under product code IZI (System, X-Ray, Angiographic), a Class II device regulated under 21 CFR 892.1600. Advance Medical Designs, Inc. has at least 10 other 510(k) clearances on record.