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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 K081886
Device Name KAREX INDUSTRIES MALE NATURAL RUBBER LATEX CONDOM, NON-SPERMICIDAL, LUBRICATED AND NON LUBRICATED
Applicant
KAREX INDUSTRIES SDN BHD
PTD. 7906/7907, TAMAN PONTIAN
JAYA, BT. 34, JALAN JOHOR
PONTIAN, JOHOR,  MY 82000
Applicant Contact LENG KIAN GOH
Correspondent
KAREX INDUSTRIES SDN BHD
PTD. 7906/7907, TAMAN PONTIAN
JAYA, BT. 34, JALAN JOHOR
PONTIAN, JOHOR,  MY 82000
Correspondent Contact LENG KIAN GOH
Regulation Number884.5300
Classification Product Code
HIS  
Date Received07/02/2008
Decision Date 02/06/2009
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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