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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 K022831
Device Name MODIFICATION TO DISETRONIC D-TRONPLUS INSULIN INFUSION PUMP
Applicant
DISETRONIC MEDICAL SYSTEMS AG
KIRCHBERSTRASSE 190, POSTFACH
BURGDORF,  SE CH-3401
Applicant Contact SANDRA SONIEC
Correspondent
DISETRONIC MEDICAL SYSTEMS AG
KIRCHBERSTRASSE 190, POSTFACH
BURGDORF,  SE CH-3401
Correspondent Contact SANDRA SONIEC
Regulation Number880.5725
Classification Product Code
LZG  
Date Received08/26/2002
Decision Date 09/11/2002
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
Recalls CDRH Recalls
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