510(k) K973899

UNIFINE PENTIPS by Owen Mumford USA, Inc. — Product Code FMI

K973899 is an FDA 510(k) premarket notification submitted by Owen Mumford USA, Inc. for the device "UNIFINE PENTIPS". The FDA issued a decision of Substantially Equivalent on December 4, 1997. The device falls under product code FMI (Needle, Hypodermic, Single Lumen), a Class II device regulated under 21 CFR 880.5570. Owen Mumford USA, Inc. has at least 9 other 510(k) clearances on record.