510(k) K993385

AUTOJET 2 (NON-FIXED NEEDLE TYPE) by Owen Mumford USA, Inc. — Product Code KZH

K993385 is an FDA 510(k) premarket notification submitted by Owen Mumford USA, Inc. for the device "AUTOJET 2 (NON-FIXED NEEDLE TYPE)". The FDA issued a decision of Substantially Equivalent on November 10, 1999. The device falls under product code KZH (Introducer, Syringe Needle), a Class II device regulated under 21 CFR 880.6920. Owen Mumford USA, Inc. has at least 9 other 510(k) clearances on record.