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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 K120206
Device Name MEDTRONIC MINIMED PARADIGM INSULIN PUMPS
Applicant
Medtronic Minimed
18000 Devonshire St.
Northridge,  CA  91325 -1219
Applicant Contact TAMAR JAGHASBANIAN
Correspondent
Medtronic Minimed
18000 Devonshire St.
Northridge,  CA  91325 -1219
Correspondent Contact TAMAR JAGHASBANIAN
Regulation Number880.5725
Classification Product Code
LZG  
Date Received01/23/2012
Decision Date 03/29/2012
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Statement Statement
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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