FDA 510(k) Application Details - K954942

Device Classification Name Tampon, Menstrual, Unscented

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510(K) Number K954942
Device Name Tampon, Menstrual, Unscented
Applicant BODYWISE (UK), LTD.
14 LOWER COURT RD.
LOWER ALMONDSBURY
BRISTOL, AVON BS32 4DX GB
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Contact S. P. HEWSON
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Regulation Number 884.5470

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Classification Product Code HEB
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Date Received 10/30/1995
Decision Date 01/25/1996
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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