Device Classification Name |
Catheter, Assisted Reproduction
|
510(k) Number |
K162878 |
Device Name |
Kitazato ET Catheters |
Applicant |
Kitazato Corporation |
1-1-8 Shibadaimon, Minato-ku |
Tokyo,
JP
105-0012
|
|
Applicant Contact |
Mari Yazaki |
Correspondent |
Emergo Global Consulting, LLC |
2500 Bee Cave Road, Building 1, Suite 300 |
Austin,
TX
78746
|
|
Correspondent Contact |
Audrey Swearingen |
Regulation Number | 884.6110
|
Classification Product Code |
|
Date Received | 10/14/2016 |
Decision Date | 07/13/2017 |
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
|
|
|