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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name tampon, menstrual, unscented
510(k) Number K142786
Device Name Ontex Unscented Tampons with Colored Plastic Applicators
5 Genthof
Buggenhout,  BE 9255
Applicant Contact Henri Lesage
Emergo Europe Consulting
Prinsessegracht 20
The Hague,  NL 2514 AP
Correspondent Contact Rachel Paul
Regulation Number884.5470
Classification Product Code
Date Received09/26/2014
Decision Date 06/23/2015
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No