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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.
# 1 Daming St., Port Industrial Zone Huada District
Guangzhou,  CN 510802
Applicant Contact Yongbing Xie
Correspondent
Guangzhou Daming United Rubber Products , Ltd.
# 1 Daming St., 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
Predetermined Change
Control Plan Authorized		 No
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