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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 K100504
Device Name V-GO DISPOSABLE INSULIN DELIVERY DEVICE, MODEL# V-GO 20, V-GO 30, V-GO40
Applicant
VALERITAS, LLC
800 BOSTON TURNPIKE
SHREWSBURY,  MA  01545
Applicant Contact SCOTT HUIE
Correspondent
VALERITAS, LLC
800 BOSTON TURNPIKE
SHREWSBURY,  MA  01545
Correspondent Contact SCOTT HUIE
Regulation Number880.5725
Classification Product Code
LZG  
Subsequent Product Code
FPA  
Date Received02/22/2010
Decision Date 12/01/2010
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
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