MALE LATEX CONDOM 56MM

Condom

PLEASURE LATEX PRODUCTS SDN. BHD.

The following data is part of a premarket notification filed by Pleasure Latex Products Sdn. Bhd. with the FDA for Male Latex Condom 56mm.

Pre-market Notification Details

Device IDK994312
510k NumberK994312
Device Name:MALE LATEX CONDOM 56MM
ClassificationCondom
Applicant PLEASURE LATEX PRODUCTS SDN. BHD. LOT 1365, 17TH MILES, JALAN SUNGAI SEMBILANG Jeram, Selangor,  MY 45800
ContactLim Koi Yong
CorrespondentLim Koi Yong
PLEASURE LATEX PRODUCTS SDN. BHD. LOT 1365, 17TH MILES, JALAN SUNGAI SEMBILANG Jeram, Selangor,  MY 45800
Product CodeHIS  
CFR Regulation Number884.5300 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeAbbreviated
3rd Party ReviewedNo
Combination ProductNo
Date Received1999-12-22
Decision Date2000-03-21

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00850024942615 K994312 000

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