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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 K031541
Device Name PARADIGMPAL, MODEL MMT-7330
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  
Date Received05/16/2003
Decision Date 11/18/2003
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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