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FDA 510(k) Application Details - K132595
Device Classification Name
Tampon, Menstrual, Unscented
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510(K) Number
K132595
Device Name
Tampon, Menstrual, Unscented
Applicant
ONTEX BVBA
PRINSESSEGRACHT 20
THE HAGUE 2514AP NL
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Contact
RACHEL PAUL
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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
08/19/2013
Decision Date
04/23/2014
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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