FDA 510(k) Application Details - K223749

Device Classification Name Tampon, Menstrual, Unscented

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510(K) Number K223749
Device Name Tampon, Menstrual, Unscented
Applicant Kimberly-Clark Corporation
2100 Winchester Road
Neenah, WI 54956 US
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Contact Jeremy Paulsen
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Regulation Number 884.5470

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Classification Product Code HEB
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Date Received 12/14/2022
Decision Date 01/06/2023
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 Y
Expedited Review



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