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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
Original Applicant
MEDTRONIC MINIMED
18000 devonshire st.
northridge,  CA  91325 -1219
Original 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
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