Water Based Personal Lubricant With Flavours

Lubricant, Personal

KAREX INDUSTRIES SDN. BHD.

The following data is part of a premarket notification filed by Karex Industries Sdn. Bhd. with the FDA for Water Based Personal Lubricant With Flavours.

Pre-market Notification Details

Device IDK150743
510k NumberK150743
Device Name:Water Based Personal Lubricant With Flavours
ClassificationLubricant, Personal
Applicant KAREX INDUSTRIES SDN. BHD. PTD 7906 & 7907, TAMAN PONTIAN JAYA, BATU 34, JALAN JOHOR Pontian,  MY 82000
ContactMs. Mary Goh Yin
CorrespondentMs. Mary Goh Yin
KAREX INDUSTRIES SDN. BHD. PTD 7906 & 7907, TAMAN PONTIAN JAYA, BATU 34, JALAN JOHOR Pontian,  MY 82000
Product CodeNUC  
CFR Regulation Number884.5300 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeAbbreviated
3rd Party ReviewedNo
Combination ProductNo
Date Received2015-03-23
Decision Date2015-11-12

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