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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 K844792
Device Name MINIMED EXTERNAL INFUSION PUMP FOR DIABETICS 502A
Applicant
Pacesetter Systems
12884 Bradley Ave.
Sylmar,  CA  91342
Applicant Contact NESTOR KUSNIERZ
Correspondent
Pacesetter Systems
12884 Bradley Ave.
Sylmar,  CA  91342
Correspondent Contact NESTOR KUSNIERZ
Regulation Number880.5725
Classification Product Code
FRN  
Date Received12/10/1984
Decision Date 01/22/1985
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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