ORANGE COLORED CONDOMS ORANGE SCENT

Condom

KAREX INDUSTRIES SDN BHD

The following data is part of a premarket notification filed by Karex Industries Sdn Bhd with the FDA for Orange Colored Condoms Orange Scent.

Pre-market Notification Details

Device IDK113056
510k NumberK113056
Device Name:ORANGE COLORED CONDOMS ORANGE SCENT
ClassificationCondom
Applicant KAREX INDUSTRIES SDN BHD PTD. 7906/7907, TAMAN PONTIAN JAYA, BT. 34, JALAN JOHOR Pontian, Johor,  MY 82000
ContactLai Peng Lim
CorrespondentLai Peng Lim
KAREX INDUSTRIES SDN BHD PTD. 7906/7907, TAMAN PONTIAN JAYA, BT. 34, JALAN JOHOR Pontian, Johor,  MY 82000
Product CodeHIS  
CFR Regulation Number884.5300 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2011-10-14
Decision Date2012-07-03

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