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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 K113036
Device Name U BY KOTEX CLICK UNSCENTED MENSTRUAL TAMPONS
Applicant
KIMBERLY-CLARK CORPORATION
2001 MARATHON AVE
NEEAH,  WI  54956
Applicant Contact LORI BARR
Correspondent
KIMBERLY-CLARK CORPORATION
2001 MARATHON AVE
NEEAH,  WI  54956
Correspondent Contact LORI BARR
Regulation Number884.5470
Classification Product Code
HEB  
Date Received10/12/2011
Decision Date 11/02/2011
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
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