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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 K030531
Device Name MEDTRONIC MINIMED PARADIGM MODEL 512 INSULIN PUMP AND THE BD PARADIGM LINK GLUCOSE METER
Applicant
MINIMED, INC.
18000 DEVONSHIRE ST.
NORTHRIDGE,  CA  91325
Applicant Contact GERDA P RESCH
Correspondent
MINIMED, INC.
18000 DEVONSHIRE ST.
NORTHRIDGE,  CA  91325
Correspondent Contact GERDA P RESCH
Regulation Number880.5725
Classification Product Code
LZG  
Subsequent Product Code
NBW  
Date Received02/19/2003
Decision Date 06/17/2003
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 Yes
Recalls CDRH Recalls
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