Ontex And Other Proprietary Names

Tampon, Menstrual, Unscented

ONTEX BVBA

The following data is part of a premarket notification filed by Ontex Bvba with the FDA for Ontex And Other Proprietary Names.

Pre-market Notification Details

Device IDK162746
510k NumberK162746
Device Name:Ontex And Other Proprietary Names
ClassificationTampon, Menstrual, Unscented
Applicant ONTEX BVBA 5 Genthof Buggenhout Oost-vlaanderen,  BE 9255
ContactHenri Lesage
CorrespondentRachel Paul
Emergo Europe Consulting Prinsessegracht 20 The Hague,  NL 2514 Ap
Product CodeHEB  
CFR Regulation Number884.5470 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2016-09-30
Decision Date2017-03-03
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00860006387723 K162746 000
00860006387716 K162746 000
00860006387709 K162746 000

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