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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 K112635
Device Name U BY KOTEX SLEEK UNSCENTED MENSTRUAL TAMPONS
Applicant
Kimberly-Clark Corp.
1400 Holcomb Bridge Rd.
Roswell,  GA  30076
Applicant Contact Swarna Mukund
Correspondent
Kimberly-Clark Corp.
1400 Holcomb Bridge Rd.
Roswell,  GA  30076
Correspondent Contact Swarna Mukund
Regulation Number884.5470
Classification Product Code
HEB  
Date Received09/09/2011
Decision Date 10/07/2011
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
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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