MALE NATURAL RUBBER LATEX CONDOM

Condom

INNOLATEX SDN. BHD

The following data is part of a premarket notification filed by Innolatex Sdn. Bhd with the FDA for Male Natural Rubber Latex Condom.

Pre-market Notification Details

Device IDK010919
510k NumberK010919
Device Name:MALE NATURAL RUBBER LATEX CONDOM
ClassificationCondom
Applicant INNOLATEX SDN. BHD NO 16, JALAN BULAN U5/5 BANDAR PINGGIRAN SUBANG, Shah Alam,selangor Darul Ehsan,  MY
ContactChang Ah-kau
CorrespondentChang Ah-kau
INNOLATEX SDN. BHD NO 16, JALAN BULAN U5/5 BANDAR PINGGIRAN SUBANG, Shah Alam,selangor Darul Ehsan,  MY
Product CodeHIS  
CFR Regulation Number884.5300 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeAbbreviated
3rd Party ReviewedNo
Combination ProductNo
Date Received2001-03-27
Decision Date2001-06-15

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00850836007328 K010919 000

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