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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 K191666
Device Name Unscented W long plastic and cardboard applicator tampons
Applicant
ONTEX BVBA
5 Genthof
Buggenhout Oost - Vlaanderen,  BE 9255
Applicant Contact Henri Lesage
Correspondent
Emergo Europe Consulting
Prinsessegracht 20
The Hague,  NL 2514AP
Correspondent Contact Rachel Paul
Regulation Number884.5470
Classification Product Code
HEB  
Date Received06/21/2019
Decision Date 12/20/2019
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
Predetermined Change
Control Plan Authorized		 No
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