Device Classification Name |
Colposcope (And Colpomicroscope)
|
510(k) Number |
K061306 |
Device Name |
CO-1000 COLPOSCOPE, MULTIPLE |
Applicant |
GYNEX CORP. |
2789 152ND AVE., NE |
REDMOND,
WA
98052
|
|
Applicant Contact |
KAREN CARDIFF |
Correspondent |
GYNEX CORP. |
2789 152ND AVE., NE |
REDMOND,
WA
98052
|
|
Correspondent Contact |
KAREN CARDIFF |
Regulation Number | 884.1630
|
Classification Product Code |
|
Date Received | 05/10/2006 |
Decision Date | 08/07/2006 |
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
|
|
|