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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 K954826
Device Name DISETRONIC MULTIFUSE PUMP SYSTEM
Applicant
Disetronic Medical Systems
5201 E. River Rd.
Suite 312
Minneapolis,  MN  55421 -1014
Applicant Contact ROBERT CERZA
Correspondent
Disetronic Medical Systems
5201 E. River Rd.
Suite 312
Minneapolis,  MN  55421 -1014
Correspondent Contact ROBERT CERZA
Regulation Number880.5725
Classification Product Code
FRN  
Date Received10/20/1995
Decision Date 05/24/1996
Decision SE SUBJECT TO TRACKING REG (ST)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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