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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 K113056
Device Name ORANGE COLORED CONDOMS ORANGE SCENT
Applicant
Karex Industries Sdn. Bhd.
Ptd. 7906/7907, Taman Pontian
Jaya, Bt. 34, Jalan Johor
Pontian Kecil, Jalan Johor,  MY 82000
Applicant Contact LAI PENG LIM
Correspondent
Karex Industries Sdn. Bhd.
Ptd. 7906/7907, Taman Pontian
Jaya, Bt. 34, Jalan Johor
Pontian Kecil, Jalan Johor,  MY 82000
Correspondent Contact LAI PENG LIM
Regulation Number884.5300
Classification Product Code
HIS  
Date Received10/14/2011
Decision Date 07/03/2012
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Statement Statement
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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