510(k) K841306

HEPARIN LOCK FLUSH SOLUTION USP KIT,100 by Solo Pak Laboratories — Product Code FMI

K841306 is an FDA 510(k) premarket notification submitted by Solo Pak Laboratories for the device "HEPARIN LOCK FLUSH SOLUTION USP KIT,100". The FDA issued a decision of Substantially Equivalent on June 4, 1984. The device falls under product code FMI (Needle, Hypodermic, Single Lumen), a Class II device regulated under 21 CFR 880.5570. Solo Pak Laboratories has at least 3 other 510(k) clearances on record.