Device Classification Name |
cannula, manipulator/injector, uterine
|
510(k) Number |
K122820 |
Device Name |
VIKY UP |
Applicant |
ENDOCONTROL |
5 avenue du Grand Sablon |
La Tronche,
FR
38700
|
|
Applicant Contact |
HUGUEL CARINE |
Correspondent |
ENDOCONTROL |
5 avenue du Grand Sablon |
La Tronche,
FR
38700
|
|
Correspondent Contact |
HUGUEL CARINE |
Regulation Number | 884.4530
|
Classification Product Code |
|
Date Received | 09/14/2012 |
Decision Date | 06/18/2013 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Obstetrics/Gynecology
|
510k Review Panel |
Obstetrics/Gynecology
|
Summary |
Summary
|
Type |
Traditional
|
Clinical Trials |
NCT01531504
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|