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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 K023471
Device Name DISETRONIC H-TRONPLUS INSULIN INFUSION PUMP
Applicant
Disetronic Medical Systems AG
5151 Program Ave.
St. Paul,  MN  55112 -1014
Applicant Contact DAVID E CHADWICK
Correspondent
Disetronic Medical Systems AG
5151 Program Ave.
St. Paul,  MN  55112 -1014
Correspondent Contact DAVID E CHADWICK
Regulation Number880.5725
Classification Product Code
LZG  
Date Received10/15/2002
Decision Date 10/29/2002
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
Recalls CDRH Recalls
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