NON-SPERMICIDAL LUBRICATED MALE LATEX CONDOM

Condom

INNOLATEX SDN. BHD

The following data is part of a premarket notification filed by Innolatex Sdn. Bhd with the FDA for Non-spermicidal Lubricated Male Latex Condom.

Pre-market Notification Details

Device IDK002393
510k NumberK002393
Device Name:NON-SPERMICIDAL LUBRICATED MALE 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 Received2000-08-07
Decision Date2000-12-19

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00812420030037 K002393 000
00850836007410 K002393 000
00850836007342 K002393 000
00850836007250 K002393 000
00850836007212 K002393 000
00850002174205 K002393 000
00850002174199 K002393 000
20812420030031 K002393 000

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