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FDA 510(k) Application Details - K040335
Device Classification Name
Cup, Menstrual
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510(K) Number
K040335
Device Name
Cup, Menstrual
Applicant
MOONCUP LLC
ONE EAST MAIN STREET
MADISON, WI 53701 US
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Contact
MORRIS WAXLER
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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
02/11/2004
Decision Date
03/30/2005
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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