510(k) K991203

IRRIGATION OR INFUSION PUMP K PUMP by Kmi Kolster Methods, Inc. — Product Code FRN

K991203 is an FDA 510(k) premarket notification submitted by Kmi Kolster Methods, Inc. for the device "IRRIGATION OR INFUSION PUMP K PUMP". The FDA issued a decision of Substantially Equivalent on October 15, 1999. The device falls under product code FRN (Pump, Infusion), a Class II device regulated under 21 CFR 880.5725. Kmi Kolster Methods, Inc. has at least 5 other 510(k) clearances on record.