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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 K843548
Device Name INTERMEDICS SYRINGE PUMP 710-02
Applicant
Intermedics, Inc.
P.O. Box 617
Freeport,  TX  77541
Applicant Contact DAVID M MAKANANI
Correspondent
Intermedics, Inc.
P.O. Box 617
Freeport,  TX  77541
Correspondent Contact DAVID M MAKANANI
Regulation Number880.5725
Classification Product Code
FRN  
Date Received09/10/1984
Decision Date 10/31/1984
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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