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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, Scented, Scented-Deodorized
510(k) Number K132208
Device Name ONTEX AND OTHERS PROPRIETARY NAMES
Applicant
Ontex Bvba
Prinsessegracht 20
The Hague,  NL
Applicant Contact RACHEL PAUL
Correspondent
Ontex Bvba
Prinsessegracht 20
The Hague,  NL
Correspondent Contact RACHEL PAUL
Regulation Number884.5460
Classification Product Code
HIL  
Date Received07/16/2013
Decision Date 04/10/2014
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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