510(k) K991758

MONOJECT INSULIN SYRINGE by The Kendal Co. — Product Code FMF

K991758 is an FDA 510(k) premarket notification submitted by The Kendal Co. for the device "MONOJECT INSULIN SYRINGE". The FDA issued a decision of Substantially Equivalent on June 14, 1999. The device falls under product code FMF (Syringe, Piston), a Class II device regulated under 21 CFR 880.5860. The Kendal Co. has at least 10 other 510(k) clearances on record.