ULTRA THIN MALE LATEX CONDOM WITH SILICONE LUBRICANT

Condom

INNOLATEX SDN. BHD

The following data is part of a premarket notification filed by Innolatex Sdn. Bhd with the FDA for Ultra Thin Male Latex Condom With Silicone Lubricant.

Pre-market Notification Details

Device IDK012665
510k NumberK012665
Device Name:ULTRA THIN MALE LATEX CONDOM WITH SILICONE LUBRICANT
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)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2001-08-13
Decision Date2001-11-09

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00812420030044 K012665 000
00850836007373 K012665 000
20812420030048 K012665 000

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