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FDA 510(k) Application Details - K131543
Device Classification Name
Tampon, Menstrual, Unscented
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510(K) Number
K131543
Device Name
Tampon, Menstrual, Unscented
Applicant
PROCTER & GAMBLE CO.
6110 CENTER HILL AVE.
CINCINNATI, OH 45224 US
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Contact
KATHLEEN BLIESZNER
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Regulation Number
884.5470
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Classification Product Code
HEB
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More FDA Info for this Product Code
Date Received
05/29/2013
Decision Date
06/20/2013
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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