FDA 510(k) Application Details - K992493

Device Classification Name Tampon, Menstrual, Unscented

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510(K) Number K992493
Device Name Tampon, Menstrual, Unscented
Applicant ANOTHERWAY PRODUCTS LLC.
910 NORTH WARD RD.
RAYMORE, MO 64083 US
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Contact STEVEN A KILGORE
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Regulation Number 884.5470

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Classification Product Code HEB
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Date Received 07/26/1999
Decision Date 11/06/2000
Decision SESE - SUBST EQUIV
Classification Advisory Committee OB - Obstetrics/Gynecology
Review Advisory Committee OB - Obstetrics/Gynecology
Statement / Summary / Purged Status Statement
Type Traditional
Reviewed By Third Party N
Expedited Review



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