FDA 510(k) Application Details - K133244

Device Classification Name Tampon, Menstrual, Unscented

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510(K) Number K133244
Device Name Tampon, Menstrual, Unscented
Applicant THE PROCTER & GAMBLE COMPANY
6110 CENTER HILL AVENUE
CINCINNATI, OH 45224 US
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Contact KATHLEEN BLIESZNER, PH.D.
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Regulation Number 884.5470

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Classification Product Code HEB
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Date Received 10/22/2013
Decision Date 01/09/2014
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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