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FDA 510(k) Application Details - K070965
Device Classification Name
Cup, Menstrual
More FDA Info for this Device
510(K) Number
K070965
Device Name
Cup, Menstrual
Applicant
ALICIA INTERNATIONAL PTY LTD.
P.O. BOX 1471
OXENFORD, QUEENSLAND 4210 AU
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Contact
TOM STONE
Other 510(k) Applications for this Contact
Regulation Number
884.5400
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Classification Product Code
HHE
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More FDA Info for this Product Code
Date Received
04/05/2007
Decision Date
03/05/2008
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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