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 IDK053367
510k NumberK053367
Device Name:MALE NATURAL RUBBER LATEX CONDOM
ClassificationCondom
Applicant INNOLATEX SDN. BHD PANDAMARAN INDUSTRIAL ESTATE PORT KLANG Selangor Darul Ehsan,  MY 42000
ContactGoh Miah Kiat
CorrespondentGoh Miah Kiat
INNOLATEX SDN. BHD PANDAMARAN INDUSTRIAL ESTATE PORT KLANG Selangor Darul Ehsan,  MY 42000
Product CodeHIS  
CFR Regulation Number884.5300 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeAbbreviated
3rd Party ReviewedNo
Combination ProductNo
Date Received2005-12-05
Decision Date2006-02-21

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