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FDA 510(k) Application Details - K091084
Device Classification Name
Tampon, Menstrual, Unscented
More FDA Info for this Device
510(K) Number
K091084
Device Name
Tampon, Menstrual, Unscented
Applicant
COTTON HIGH TECH SL
CTRA NAVAS A PRATS DE LLUCANES
KM 1,5 GAIA
BARCELONA 08679 ES
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Contact
ELENA GOMEZ
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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
04/15/2009
Decision Date
04/29/2009
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
Y
Expedited Review
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