510(k) K043204

SGARLATO LABS PAINFREE PUMP AND PAIN CONTROL INFUSION PUMP by Sgarlato Laboratories, Inc. — Product Code FRN

K043204 is an FDA 510(k) premarket notification submitted by Sgarlato Laboratories, Inc. for the device "SGARLATO LABS PAINFREE PUMP AND PAIN CONTROL INFUSION PUMP". The FDA issued a decision of Substantially Equivalent on March 30, 2005. The device falls under product code FRN (Pump, Infusion), a Class II device regulated under 21 CFR 880.5725. Sgarlato Laboratories, Inc. has at least 7 other 510(k) clearances on record.