FDA 510(k) Application Details - K081555

Device Classification Name Tampon, Menstrual, Scented, Deodorized

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510(K) Number K081555
Device Name Tampon, Menstrual, Scented, Deodorized
Applicant PROCTER & GAMBLE CO.
6110 CENTER HILL AVE.
CINCINNATI, OH 45224 US
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Contact LENORE FAULHABER
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Regulation Number 884.5460

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Classification Product Code HIL
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Date Received 06/03/2008
Decision Date 06/27/2008
Decision SESE - SUBST EQUIV
Classification Advisory Committee OB - Obstetrics/Gynecology
Review Advisory Committee OB - Obstetrics/Gynecology
Statement / Summary / Purged Status Summary
Type Special
Reviewed By Third Party N
Expedited Review



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