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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, Insulin
510(k) Number K021725
Device Name DISETRONIC D-TRON INSULIN INFUSION PUMP
Applicant
Disetronic Medical Systems AG
Kirchberstrasse 190, Postfach
Burgdorf,  CH CH-3401
Applicant Contact SANDRA SONIEC
Correspondent
Disetronic Medical Systems AG
Kirchberstrasse 190, Postfach
Burgdorf,  CH CH-3401
Correspondent Contact SANDRA SONIEC
Regulation Number880.5725
Classification Product Code
LZG  
Date Received05/24/2002
Decision Date 08/02/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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