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FDA 510(k) Application Details - K050094
Device Classification Name
Device, Fertility Diagnostic, Proceptive
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510(K) Number
K050094
Device Name
Device, Fertility Diagnostic, Proceptive
Applicant
LADY COMP USA
410 EAST TERRACE HEIGHTS
JEFFERSONVILLE, IN 47130 US
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Contact
MICHAEL CARTAIN
Other 510(k) Applications for this Contact
Regulation Number
000.0000
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Classification Product Code
LHD
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More FDA Info for this Product Code
Date Received
01/14/2005
Decision Date
04/20/2006
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
-
Review Advisory Committee
OB - Obstetrics/Gynecology
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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