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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 K153016
Device Name aoni Natural Rubber Latex Condom
Applicant
Guangzhou Daming United Rubber Products Ltd.
NO. 1 Daming Street, Port Industrial Zone Huada District
guangzhou,  CN 510802
Applicant Contact yongbing xie
Correspondent
Guangzhou Daming United Rubber Products Ltd.
NO. 1 Daming Street, Port Industrial Zone Huada District
guangzhou,  CN 510802
Correspondent Contact yongbing xie
Regulation Number884.5300
Classification Product Code
HIS  
Date Received10/15/2015
Decision Date 10/20/2016
Decision substantially equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
summary summary
Type Abbreviated
Reviewed by Third Party No
Combination Product No
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