THAI NIPPON 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 Male Latex Condom.

Pre-market Notification Details

Device IDK081265
510k NumberK081265
Device Name:THAI NIPPON MALE LATEX CONDOM
ClassificationCondom
Applicant THAI NIPPON RUBBER INDUSTRY CO., LTD. PO BOX 12139 Durham,  NC  27709
ContactEli J Carter
CorrespondentEli J Carter
THAI NIPPON RUBBER INDUSTRY CO., LTD. PO BOX 12139 Durham,  NC  27709
Product CodeHIS  
CFR Regulation Number884.5300 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeAbbreviated
3rd Party ReviewedNo
Combination ProductNo
Date Received2008-05-05
Decision Date2009-10-16
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00850281004477 K081265 000
00850281004460 K081265 000
00850281004453 K081265 000

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