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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 K032164
Device Name DIABETES DATA MANAGEMENT SYSTEM (DDMS), MODEL 7333
Applicant
Medtronic Minimed
18000 Devonshire St.
Northridge,  CA  91325 -1219
Applicant Contact GERDA P RESCH
Correspondent
Medtronic Minimed
18000 Devonshire St.
Northridge,  CA  91325 -1219
Correspondent Contact GERDA P RESCH
Regulation Number880.5725
Classification Product Code
LZG  
Date Received07/15/2003
Decision Date 10/23/2003
Decision Substantially Equivalent (SESE)
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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