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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name warmer, thermal, infusion fluid
510(k) Number K031390
Device Name MEDTRONIC MINIMED PARADIGM INSULIN PUMP, MODEL MMT-712
Applicant
MINIMED, INC.
18000 DEVONSHIRE ST.
NORTHRIDGE,  CA  91325
Applicant Contact MIRIELLE MENGOTTO
Correspondent
MINIMED, INC.
18000 DEVONSHIRE ST.
NORTHRIDGE,  CA  91325
Correspondent Contact MIRIELLE MENGOTTO
Regulation Number880.5725
Classification Product Code
LGZ  
Date Received05/02/2003
Decision Date 07/23/2003
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
Recalls CDRH Recalls
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