510(k) K831765

HERAPIN LOCK FLUSH SOLUTION USE KIT by Smith & Nephew, Mpl Division — Product Code FMI

K831765 is an FDA 510(k) premarket notification submitted by Smith & Nephew, Mpl Division for the device "HERAPIN LOCK FLUSH SOLUTION USE KIT". The FDA issued a decision of Substantially Equivalent on July 12, 1983. The device falls under product code FMI (Needle, Hypodermic, Single Lumen), a Class II device regulated under 21 CFR 880.5570. Smith & Nephew, Mpl Division has at least 8 other 510(k) clearances on record.