Device Classification Name |
Colposcope (And Colpomicroscope)
|
510(k) Number |
K132423 |
Device Name |
THE GYNOCULAR |
Applicant |
GYNIUS AB |
DOBELNSGATAN 23 |
STOCKHOLM,
SE
11140
|
|
Applicant Contact |
MATTHEW VOLSKY |
Correspondent |
GYNIUS AB |
DOBELNSGATAN 23 |
STOCKHOLM,
SE
11140
|
|
Correspondent Contact |
MATTHEW VOLSKY |
Regulation Number | 884.1630
|
Classification Product Code |
|
Date Received | 08/05/2013 |
Decision Date | 04/08/2014 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Obstetrics/Gynecology
|
510k Review Panel |
Obstetrics/Gynecology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|