MAXIMA, TRUSTEX, RIA AND PREMIUM CONDOMS

Condom

LS RUBBER SDN BHD

The following data is part of a premarket notification filed by Ls Rubber Sdn Bhd with the FDA for Maxima, Trustex, Ria And Premium Condoms.

Pre-market Notification Details

Device IDK980964
510k NumberK980964
Device Name:MAXIMA, TRUSTEX, RIA AND PREMIUM CONDOMS
ClassificationCondom
Applicant LS RUBBER SDN BHD 2443 FILLMORE ST. SUITE 135 San Francisco,  CA  91115
ContactMohamad Firdaos Bin Mohamed
CorrespondentMohamad Firdaos Bin Mohamed
LS RUBBER SDN BHD 2443 FILLMORE ST. SUITE 135 San Francisco,  CA  91115
Product CodeHIS  
CFR Regulation Number884.5300 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1998-03-16
Decision Date1999-03-12

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