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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Pump, Infusion
510(k) Number K893488
Device Name PULSATILE PUMP FOR GONADORELIN ACETATE
Applicant
Ortho Pharmaceutical Corp.
Rte. 202, P.O. Box 300
Raritan,  NJ  08869
Applicant Contact J HUME
Correspondent
Ortho Pharmaceutical Corp.
Rte. 202, P.O. Box 300
Raritan,  NJ  08869
Correspondent Contact J HUME
Regulation Number880.5725
Classification Product Code
FRN  
Date Received05/04/1989
Decision Date 10/31/1989
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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