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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
Applicant
ONTEX BVBA
5 Genthof
Buggenhout,  BE 9255
Applicant Contact Henri Lesage
Correspondent
Emergo Europe Consulting
Prinsessegracht 20
The Hague,  NL 2514 AP
Correspondent Contact Rachel Paul
Regulation Number884.5470
Classification Product Code
HEB  
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
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