510(k) K864761

USI AUTOJECT INSULIN SYRINGE by Ulster Scientific, Inc. — Product Code FMF

K864761 is an FDA 510(k) premarket notification submitted by Ulster Scientific, Inc. for the device "USI AUTOJECT INSULIN SYRINGE". The FDA issued a decision of Substantially Equivalent on Dec 16, 1986. The device falls under product code FMF (Syringe, Piston), a Class II device regulated under 21 CFR 880.5860. Ulster Scientific, Inc. has at least 10 other 510(k) clearances on record.