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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 K905693
Device Name H-TRON V 100 INSULIN INFUSION PUMP
Applicant
DISETRONIC MEDICAL SYSTEMS
13911 RIDGEDALE DR.
SUITE 254
MINNETONKA,  MN  55343
Applicant Contact JIM MYERS
Correspondent
DISETRONIC MEDICAL SYSTEMS
13911 RIDGEDALE DR.
SUITE 254
MINNETONKA,  MN  55343
Correspondent Contact JIM MYERS
Regulation Number880.5725
Classification Product Code
LZG  
Date Received12/19/1990
Decision Date 04/12/1991
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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