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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 K103311
Device Name U BY KOTEX CLICK UNSCENTED MENSTRUL TAMPONS
Applicant
Kimberly Clark Corporation
2100 Winchester Rd.
Neenah,  WI  54956
Applicant Contact CHERYL SANZARE
Correspondent
Kimberly Clark Corporation
2100 Winchester Rd.
Neenah,  WI  54956
Correspondent Contact CHERYL SANZARE
Regulation Number884.5470
Classification Product Code
HEB  
Date Received11/10/2010
Decision Date 12/10/2010
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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