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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 K162746
Device Name Ontex and other proprietary names
Applicant
ONTEX BVBA
5 Genthof
Buggenhout Oost-Vlaanderen,  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 Received09/30/2016
Decision Date 03/03/2017
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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