510(k) K894372

NIPRO NEEDLE HOLDER by Pharma-Plast USA, Inc. — Product Code FMI

K894372 is an FDA 510(k) premarket notification submitted by Pharma-Plast USA, Inc. for the device "NIPRO NEEDLE HOLDER". The FDA issued a decision of Substantially Equivalent on September 28, 1989. The device falls under product code FMI (Needle, Hypodermic, Single Lumen), a Class II device regulated under 21 CFR 880.5570. Pharma-Plast USA, Inc. has at least 8 other 510(k) clearances on record.