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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Set, Administration, Intravascular
510(k) Number K032484
Device Name MEDTRONIC MINIMED PARADIGM COUNTACH INFUSION SET, MODEL MMT 310
Applicant
Medtronic Minimed
18000 Devonshire St.
Northridge,  CA  91325 -1219
Applicant Contact MIRIELLE MENGOTTO
Correspondent
Medtronic Minimed
18000 Devonshire St.
Northridge,  CA  91325 -1219
Correspondent Contact MIRIELLE MENGOTTO
Regulation Number880.5440
Classification Product Code
FPA  
Subsequent Product Code
FPK  
Date Received08/12/2003
Decision Date 10/28/2003
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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