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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 K853192
Device Name KOTEX SECURITY TUBE TAMPON
Applicant
KIMBERLY-CLARK CORP.
2100 WINCHESTER RD.
P.O. BOX 2001
NEENAH,  WI  54957 -2001
Applicant Contact BONNIE B WAN
Correspondent
KIMBERLY-CLARK CORP.
2100 WINCHESTER RD.
P.O. BOX 2001
NEENAH,  WI  54957 -2001
Correspondent Contact BONNIE B WAN
Regulation Number884.5470
Classification Product Code
HEB  
Date Received07/30/1985
Decision Date 08/29/1985
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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