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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 K103825
Device Name V-GO INSULIN DELIVERY SYSTEM
Applicant
VALERITAS, INC.
800 BOSTON TURNPIKE
SHREWSBURY,  MA  01545
Applicant Contact SCOTT HUIE
Correspondent
VALERITAS, INC.
800 BOSTON TURNPIKE
SHREWSBURY,  MA  01545
Correspondent Contact SCOTT HUIE
Regulation Number880.5725
Classification Product Code
LZG  
Subsequent Product Code
FPA  
Date Received12/30/2010
Decision Date 02/23/2011
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
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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