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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 -8409
Applicant Contact ROBERT SEIPLE
Correspondent
COTTONS PTY, LTD
3817 SEVILLE RD.
DENTON,  TX  76205 -8409
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
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