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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 K083817
Device Name M. DIOR BRAND
Applicant
SUZHOU COLOUR-WAY ENTERPRISE DEVELOPMENT CO., LTD.
RM. 1606, BLDG. 1, JIANXIANG -
YUAN NO.209 BEI SI HUAN ZHONG
haidian district, beijing,  CN 100083
Applicant Contact chu xiaoan
Correspondent
SUZHOU COLOUR-WAY ENTERPRISE DEVELOPMENT CO., LTD.
RM. 1606, BLDG. 1, JIANXIANG -
YUAN NO.209 BEI SI HUAN ZHONG
haidian district, beijing,  CN 100083
Correspondent Contact chu xiaoan
Regulation Number884.5300
Classification Product Code
HIS  
Date Received12/22/2008
Decision Date 09/16/2009
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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