SPERMICIDAL LUBRICATED MALE LATEX CONDOM

Condom With Nonoxynol-9

INNOLATEX SDN. BHD

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

Pre-market Notification Details

Device IDK010178
510k NumberK010178
Device Name:SPERMICIDAL LUBRICATED MALE LATEX CONDOM
ClassificationCondom With Nonoxynol-9
Applicant INNOLATEX SDN. BHD NO. 16, JALAN BULAN U5/5, BANDAR PINGGIRAN SUBANG Shah Alam, Selangor D.e.,  MY 40150
ContactChang Au-kau
CorrespondentChang Au-kau
INNOLATEX SDN. BHD NO. 16, JALAN BULAN U5/5, BANDAR PINGGIRAN SUBANG Shah Alam, Selangor D.e.,  MY 40150
Product CodeLTZ  
CFR Regulation Number884.5310 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeAbbreviated
3rd Party ReviewedNo
Combination ProductNo
Date Received2001-01-19
Decision Date2001-04-27

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