510(k) K833706

CLICK-COUNT U100 INSULIN SYRINGE by Orange Medical Instruments, Inc. — Product Code FMF

K833706 is an FDA 510(k) premarket notification submitted by Orange Medical Instruments, Inc. for the device "CLICK-COUNT U100 INSULIN SYRINGE". The FDA issued a decision of Substantially Equivalent on April 5, 1984. The device falls under product code FMF (Syringe, Piston), a Class II device regulated under 21 CFR 880.5860. Orange Medical Instruments, Inc. has at least 10 other 510(k) clearances on record.