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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
Recalls CDRH Recalls
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