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FDA 510(k) Application Details - K091754
Device Classification Name
Cup, Menstrual
More FDA Info for this Device
510(K) Number
K091754
Device Name
Cup, Menstrual
Applicant
LUNE GROUP LTD.
1920 ARLINGTON PLACE
MADISON, WI 53726 US
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Contact
MORRIS WAXLER
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
06/16/2009
Decision Date
11/13/2009
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
N
Expedited Review
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