510(k) K822928

DISPOSABLE MICRO-INFUSION SYSTEM by Orange Medical Instruments, Inc. — Product Code FMF

K822928 is an FDA 510(k) premarket notification submitted by Orange Medical Instruments, Inc. for the device "DISPOSABLE MICRO-INFUSION SYSTEM". The FDA issued a decision of Substantially Equivalent on October 26, 1982. 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.