510(k) K123684

SOL-CARE SAFETY NEEDLE by Sol-Millennium Medical — Product Code FMI

K123684 is an FDA 510(k) premarket notification submitted by Sol-Millennium Medical for the device "SOL-CARE SAFETY NEEDLE". The FDA issued a decision of Substantially Equivalent on May 8, 2013. The device falls under product code FMI (Needle, Hypodermic, Single Lumen), a Class II device regulated under 21 CFR 880.5570. Sol-Millennium Medical has at least 10 other 510(k) clearances on record.