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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
Device Name OMNIPOD INSULIN MANAGMENT SYSTEM
Applicant
INSULET CORPORATION
9 OAK PARK DR.
bedford,  MA  01730
Applicant Contact michael j doyle
Correspondent
INSULET CORPORATION
9 OAK PARK DR.
bedford,  MA  01730
Correspondent 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 (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
summary summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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