510(k) K182146

Sol-M Blood Collection Needles, Sol-Care Safety Blood Collection Needles, Sol-Care Safety Blood Collection Needle with Holders, Sol-M Blood Collection Set by Sol-Millennium Medical, Inc. — Product Code FMI

K182146 is an FDA 510(k) premarket notification submitted by Sol-Millennium Medical, Inc. for the device "Sol-M Blood Collection Needles, Sol-Care Safety Blood Collection Needles, Sol-Care Safety Blood Collection Needle with Holders, Sol-M Blood Collection Set". The FDA issued a decision of Substantially Equivalent on December 3, 2018. The device falls under product code FMI (Needle, Hypodermic, Single Lumen), a Class II device regulated under 21 CFR 880.5570. Sol-Millennium Medical, Inc. has at least 10 other 510(k) clearances on record.