FDA 510(k) Application Details - K960341

Device Classification Name Tampon, Menstrual, Unscented

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510(K) Number K960341
Device Name Tampon, Menstrual, Unscented
Applicant TAMBRANDS, INC.
BRIDGE & SPRINGFIELD STREETS
PALMER, MA 01069 US
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Contact JEROME B WAINICK
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Regulation Number 884.5470

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Classification Product Code HEB
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Date Received 01/24/1996
Decision Date 04/17/1996
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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