FDA 510(k) Application Details - K103311

Device Classification Name Tampon, Menstrual, Unscented

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510(K) Number K103311
Device Name Tampon, Menstrual, Unscented
Applicant KIMBERLY CLARK CORPORATION
2100 WINCHESTER ROAD
NEENAH, WI 54956 US
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Contact CHERYL SANZARE
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Regulation Number 884.5470

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Classification Product Code HEB
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Date Received 11/10/2010
Decision Date 12/10/2010
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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