Device Classification Name |
cannula, suction, uterine
|
510(k) Number |
K172151 |
Device Name |
Hysteroscopy System |
Applicant |
Chongquin Jinshan Science & Technology (Group) Co., Ltd. |
Yubei District No. 18 Ningshang Avenue Jinshan |
International Industrial City |
Chongqing,
CN
400000
|
|
Applicant Contact |
Qing Xu |
Correspondent |
Chongquin Jinshan Science & Technology (Group) Co., Ltd. |
Yubei District No. 18 Ningshang Avenue Jinshan |
International Industrial City |
Chongqing,
CN
400000
|
|
Correspondent Contact |
Qing Xu |
Regulation Number | 884.5070
|
Classification Product Code |
|
Date Received | 07/17/2017 |
Decision Date | 04/09/2018 |
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
|
|
|