Device Classification Name |
Media, Reproductive
|
510(k) Number |
K190199 |
Device Name |
SepaSperm Washing Solution, SepaSperm Solution |
Applicant |
Kitazato Corporation |
81 Nakajima |
Fuji-shi,
JP
416-0907
|
|
Applicant Contact |
Futoshi Inoue |
Correspondent |
Emergo Global Consulting, LLC |
2500 Bee Cave Road, Building 1, Suite 300 |
Austin,
TX
78746
|
|
Correspondent Contact |
Audrey Swearingen |
Regulation Number | 884.6180
|
Classification Product Code |
|
Date Received | 02/04/2019 |
Decision Date | 09/26/2019 |
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
|
|
|