Device Classification Name |
condom
|
510(k) Number |
K162919 |
Device Name |
Male Latex Condoms |
Applicant |
Zhejiang Xiangban Latex Products Co., Ltd. |
D288, Huancheng West Road, Beiyuan Industrial Zone |
Yiwu,
CN
322000
|
|
Applicant Contact |
Huichao Lou |
Correspondent |
Medwheat (Shanghai) Medical Technology Co., Ltd. |
Yangpu District Liaoyuan East Road Shuangyang |
First Suite NO.33 Room 303 |
Shanghai,
CN
200093
|
|
Correspondent Contact |
Jonathan Hu |
Regulation Number | 884.5300
|
Classification Product Code |
|
Date Received | 10/18/2016 |
Decision Date | 03/07/2017 |
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
|
|
|