FDA 510(k) Application Details - K974629

Device Classification Name Tampon, Menstrual, Unscented

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510(K) Number K974629
Device Name Tampon, Menstrual, Unscented
Applicant PERSONAL PRODUCTS CO.
199 GRANDVIEW RD.
SKILLMAN, NJ 08558 US
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Contact RALPH PETRONE
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Regulation Number 884.5470

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Classification Product Code HEB
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Date Received 12/12/1997
Decision Date 02/10/1998
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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