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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 K172118
Device Name U by Kotex Click Unscented Menstrual Tampons
Kimberly-Clark Corporation
2100 Winchester Road
Neenah,  WI  54956
Applicant Contact Charnelle Thomas
Kimberly-Clark Corp.
2001 Marathon Ave.
Neenah,  WI  54956
Correspondent Contact Lori J. Barr
Regulation Number884.5470
Classification Product Code
Date Received07/13/2017
Decision Date 10/11/2017
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