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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 K884305
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 Received10/13/1988
Decision Date 12/20/1988
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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