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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Scale, Patient
510(k) Number K920063
Device Name DISETRONIC DOLOMAT 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 Number880.2720
Classification Product Code
FRW  
Date Received01/07/1992
Decision Date 08/03/1993
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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