FLAVORED MALE LATEX CONDOM

Condom

THAI NIPPON RUBBER INDUSTRY CO., LTD.

The following data is part of a premarket notification filed by Thai Nippon Rubber Industry Co., Ltd. with the FDA for Flavored Male Latex Condom.

Pre-market Notification Details

Device IDK011253
510k NumberK011253
Device Name:FLAVORED MALE LATEX CONDOM
ClassificationCondom
Applicant THAI NIPPON RUBBER INDUSTRY CO., LTD. 1219 LITTLE CREEK RD. Durham,  NC  27713
ContactEli J Carter
CorrespondentEli J Carter
THAI NIPPON RUBBER INDUSTRY CO., LTD. 1219 LITTLE CREEK RD. Durham,  NC  27713
Product CodeHIS  
CFR Regulation Number884.5300 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeAbbreviated
3rd Party ReviewedNo
Combination ProductNo
Date Received2001-04-24
Decision Date2001-07-20

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