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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 K053367
Device Name MALE NATURAL RUBBER LATEX CONDOM
Applicant
Innolatex Sdn. Bhd
Pandamaran Industrial Estate
Port Klang
Selangor Darul Ehsan,  MY 42000
Applicant Contact GOH MIAH KIAT
Correspondent
Innolatex Sdn. Bhd
Pandamaran Industrial Estate
Port Klang
Selangor Darul Ehsan,  MY 42000
Correspondent Contact GOH MIAH KIAT
Regulation Number884.5300
Classification Product Code
HIS  
Date Received12/05/2005
Decision Date 02/21/2006
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Statement Statement
Type Abbreviated
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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