FDA 510(k) Application Details - K023789

Device Classification Name Tampon, Menstrual, Unscented

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510(K) Number K023789
Device Name Tampon, Menstrual, Unscented
Applicant MCNEIL-PPC, INC.
199 GRANDVIEW RD.
SKILLMAN, NJ 08558 US
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Contact DIANA L.B. UHL
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Regulation Number 884.5470

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Classification Product Code HEB
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Date Received 11/13/2002
Decision Date 12/06/2002
Decision SESE - SUBST EQUIV
Classification Advisory Committee OB - Obstetrics/Gynecology
Review Advisory Committee OB - Obstetrics/Gynecology
Statement / Summary / Purged Status Summary
Type Special
Reviewed By Third Party N
Expedited Review



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