510(k) K882598

250 ML BAG W/Y INJECT. & 12 EXTENSION SET by Prn Services, Inc. — Product Code FRN

K882598 is an FDA 510(k) premarket notification submitted by Prn Services, Inc. for the device "250 ML BAG W/Y INJECT. & 12 EXTENSION SET". The FDA issued a decision of Substantially Equivalent on November 1, 1988. The device falls under product code FRN (Pump, Infusion), a Class II device regulated under 21 CFR 880.5725. Prn Services, Inc. has at least 6 other 510(k) clearances on record.