510(k) K990101

PAIN CONTROL INFUSION PUMP by Sgarlato Laboratories, Inc. — Product Code FRN

K990101 is an FDA 510(k) premarket notification submitted by Sgarlato Laboratories, Inc. for the device "PAIN CONTROL INFUSION PUMP". The FDA issued a decision of Substantially Equivalent on March 19, 1999. 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.