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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 K872018
FOIA Releasable 510(k) K872018
Device Name KOTEX STICK TAMPONS, REGULAR AND SUPER
Applicant
KIMBERLY-CLARK CORP.
1201 PENNSYLVANIA AVENUE, N.W.
SUITE 730
WASHINGTON,  DC  20004
Applicant Contact BONNIE B WAN
Correspondent
KIMBERLY-CLARK CORP.
1201 PENNSYLVANIA AVENUE, N.W.
SUITE 730
WASHINGTON,  DC  20004
Correspondent Contact BONNIE B WAN
Regulation Number884.5470
Classification Product Code
HEB  
Date Received05/26/1987
Decision Date 06/24/1987
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Type Traditional
Reviewed by Third Party No
Combination Product No
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