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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 K080733
Device Name COTTONS 100% NATURAL COTTON TAMPONS
Applicant
Cottons Pty, Ltd.
3817 Seville Rd.
Denton,  TX  76205
Applicant Contact ROBERT SEIPLE
Correspondent
Cottons Pty, Ltd.
3817 Seville Rd.
Denton,  TX  76205
Correspondent Contact ROBERT SEIPLE
Regulation Number884.5470
Classification Product Code
HEB  
Date Received03/14/2008
Decision Date 02/18/2009
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Summary Summary
Type Abbreviated
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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