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 Number | 880.5725
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 02/22/2010 |
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
|
|
|