THAI NIPPON EXTRA STRENGTH 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 Thai Nippon Extra Strength Male Latex Condom.

Pre-market Notification Details

Device IDK032909
510k NumberK032909
Device Name:THAI NIPPON EXTRA STRENGTH 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 Received2003-09-17
Decision Date2003-12-16

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00850281004361 K032909 000

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