510(k) K153537

Sol-M Insulin Syringe, Sol-M TB Syringe by Sol-Millennium Medical, Inc. — Product Code FMF

K153537 is an FDA 510(k) premarket notification submitted by Sol-Millennium Medical, Inc. for the device "Sol-M Insulin Syringe, Sol-M TB Syringe". The FDA issued a decision of Substantially Equivalent on June 17, 2016. The device falls under product code FMF (Syringe, Piston), a Class II device regulated under 21 CFR 880.5860. Sol-Millennium Medical, Inc. has at least 10 other 510(k) clearances on record.