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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 K131294
Device Name OMNIPOD INSULIN MANAGEMENT SYSTEM
Applicant
INSULET CORPORATION
9 OAK PARK DR.
BEDFORD,  MA  01730
Applicant Contact TARA N TURNEY
Correspondent
INSULET CORPORATION
9 OAK PARK DR.
BEDFORD,  MA  01730
Correspondent Contact TARA N TURNEY
Regulation Number880.5725
Classification Product Code
LZG  
Date Received05/06/2013
Decision Date 08/29/2013
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
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