DUREX LATEX CONDOMS

Condom

LONDON INTL. LLC.

The following data is part of a premarket notification filed by London Intl. Llc. with the FDA for Durex Latex Condoms.

Pre-market Notification Details

Device IDK980204
510k NumberK980204
Device Name:DUREX LATEX CONDOMS
ClassificationCondom
Applicant LONDON INTL. LLC. 2926 COLUMBIA HWY. P.O. BOX 8308 Dothan,  AL  36304
ContactNeil Anderson
CorrespondentNeil Anderson
LONDON INTL. LLC. 2926 COLUMBIA HWY. P.O. BOX 8308 Dothan,  AL  36304
Product CodeHIS  
CFR Regulation Number884.5300 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1998-01-20
Decision Date1998-04-17

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.