Device Classification Name |
media, reproductive
|
510(k) Number |
K193522 |
Device Name |
iMedium Single Step; iMedium Single Step with HSA; iMedium Single Step with rHA |
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 |
Michael A. Siano |
Regulation Number | 884.6180
|
Classification Product Code |
|
Date Received | 12/19/2019 |
Decision Date | 08/25/2020 |
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
|
|
|