510(k) K052474

NIPRO HYPODERMIC NEEDLE by Nipro Medical Corp. — Product Code FMI

K052474 is an FDA 510(k) premarket notification submitted by Nipro Medical Corp. for the device "NIPRO HYPODERMIC NEEDLE". The FDA issued a decision of Substantially Equivalent on November 10, 2005. The device falls under product code FMI (Needle, Hypodermic, Single Lumen), a Class II device regulated under 21 CFR 880.5570. Nipro Medical Corp. has at least 10 other 510(k) clearances on record.