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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 K896994
Device Name KOTEX SECURITY TAMPONS (SEVERAL TYPE)
Applicant
Kimberly-Clark Corp.
1201 Pennsylvania Ave., NW
Suite 730
Washington,  DC  20004
Applicant Contact BONNIE B WAN
Correspondent
Kimberly-Clark Corp.
1201 Pennsylvania Ave., NW
Suite 730
Washington,  DC  20004
Correspondent Contact BONNIE B WAN
Regulation Number884.5470
Classification Product Code
HEB  
Date Received12/11/1989
Decision Date 12/22/1989
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
Recalls CDRH Recalls
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