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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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