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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 K073356
Device Name PARADIGM INSULIN INFUSION PUMP, MODELS MMT-512, MMT-712, MMT-515 AND MMT-715
Applicant
Medtronic Minimed
18000 Devonshire St.
Northridge,  CA  91325
Applicant Contact MARK J FAILLACE
Correspondent
Medtronic Minimed
18000 Devonshire St.
Northridge,  CA  91325
Correspondent Contact MARK J FAILLACE
Regulation Number880.5725
Classification Product Code
LZG  
Date Received11/29/2007
Decision Date 04/25/2008
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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