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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name condom
510(k) Number K162919
Device Name Male Latex Condoms
Zhejiang Xiangban Latex Products Co., Ltd.
D288, Huancheng West Road, Beiyuan Industrial Zone
Yiwu,  CN 322000
Applicant Contact Huichao Lou
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 Number884.5300
Classification Product Code
Date Received10/18/2016
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