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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 K850792
Device Name ODAC-ON DEMAND ARALGESIA BY COMPUTER-INFUSION PUMP
Applicant
Janssen Pharmaceutica, Inc.
40 Kingsbridge Rd.
Piscataway,  NJ  08854
Applicant Contact DONALD P COX
Correspondent
Janssen Pharmaceutica, Inc.
40 Kingsbridge Rd.
Piscataway,  NJ  08854
Correspondent Contact DONALD P COX
Regulation Number880.5725
Classification Product Code
FRN  
Date Received02/26/1985
Decision Date 11/13/1985
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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