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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
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