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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
Model ABSORBENCY: REGULAR, SUPER AND SUPER PLUS
Device Name U BY KOTEX SLEEK UNSCENTED MENSTRUAL TAMPONS
Applicant
KIMBERLY-CLARK CORP.
1400 holcomb bridge road
roswell,  GA  30076
Contact swarna mukund
Regulation Number884.5470
Classification Product Code
HEB  
Date Received09/09/2011
Decision Date 10/07/2011
Decision substantially equivalent (SE)
Classification Advisory Committee Obstetrics/Gynecology
Review Advisory Committee Obstetrics/Gynecology
summary summary
Type Special
Reviewed by Third Party No
Expedited Review No
Combination Product No
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