510(k) K893488

PULSATILE PUMP FOR GONADORELIN ACETATE by Ortho Pharmaceutical Corp. — Product Code FRN

K893488 is an FDA 510(k) premarket notification submitted by Ortho Pharmaceutical Corp. for the device "PULSATILE PUMP FOR GONADORELIN ACETATE". The FDA issued a decision of Substantially Equivalent on October 31, 1989. The device falls under product code FRN (Pump, Infusion), a Class II device regulated under 21 CFR 880.5725. Ortho Pharmaceutical Corp. has at least 8 other 510(k) clearances on record.