510(k) K932055

PERCUPUMP II by E-Z-Em, Inc. — Product Code FIH

K932055 is an FDA 510(k) premarket notification submitted by E-Z-Em, Inc. for the device "PERCUPUMP II". The FDA issued a decision of Substantially Equivalent on March 21, 1995. The device falls under product code FIH (Pump, Infusion Or Syringe, Extra-Luminal), a Class II device regulated under 21 CFR 876.5820. E-Z-Em, Inc. has at least 10 other 510(k) clearances on record.