Device Classification Name |
Cannula, Manipulator/Injector, Uterine
|
510(k) Number |
K131781 |
Device Name |
CLEARVIEW TOTAL |
Applicant |
CLINICAL INNOVATIONS, LLC |
747 WEST 4170 SOUTH |
MURRAY,
UT
84123
|
|
Applicant Contact |
BRIAN MCROBERTS |
Correspondent |
CLINICAL INNOVATIONS, LLC |
747 WEST 4170 SOUTH |
MURRAY,
UT
84123
|
|
Correspondent Contact |
BRIAN MCROBERTS |
Regulation Number | 884.4530
|
Classification Product Code |
|
Date Received | 06/17/2013 |
Decision Date | 05/28/2014 |
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
|
Recalls |
CDRH Recalls
|
|
|