'ONE TOUCH' LATEX CONDOM WITH NONOXYNOL-9

Condom With Nonoxynol-9

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 'one Touch' Latex Condom With Nonoxynol-9.

Pre-market Notification Details

Device IDK001978
510k NumberK001978
Device Name:'ONE TOUCH' LATEX CONDOM WITH NONOXYNOL-9
ClassificationCondom With Nonoxynol-9
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 CodeLTZ  
CFR Regulation Number884.5310 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeAbbreviated
3rd Party ReviewedNo
Combination ProductNo
Date Received2000-06-29
Decision Date2000-08-08

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