FDA 510(k) Application Details - K172118

Device Classification Name Tampon, Menstrual, Unscented

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510(K) Number K172118
Device Name Tampon, Menstrual, Unscented
Applicant Kimberly-Clark Corporation
2100 Winchester Road
Neenah, WI 54956 US
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Contact Charnelle Thomas
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Regulation Number 884.5470

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Classification Product Code HEB
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Date Received 07/13/2017
Decision Date 10/11/2017
Decision SESE - SUBST EQUIV
Classification Advisory Committee OB - Obstetrics/Gynecology
Review Advisory Committee OB - Obstetrics/Gynecology
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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