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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 K122953
Model ZXP425, PDM: UST400 (14500-5A)
Device Name OMNIPOD INSULIN MANAGMENT SYSTEM
Applicant
INSULET CORPORATION
9 oak park dr.
bedford,  MA  01730
Contact michael j doyle
Regulation Number880.5725
Classification Product Code
LZG  
Subsequent Product Code
NBW  
Date Received09/25/2012
Decision Date 12/07/2012
Decision substantially equivalent (SE)
Classification Advisory Committee General Hospital
Review Advisory Committee General Hospital
summary summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
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