V-GO INSULIN DELIVERY SYSTEM


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

Correspodent Contact scott huie
Regulation Number 880.5725
Classification Product Code
LZG  
Subsequent Product Code
FPA  
Date Received 12/30/2010
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