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FDA 510(k) Application Details - K072381
Device Classification Name
Spatula, Cervical, Cytological
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510(K) Number
K072381
Device Name
Spatula, Cervical, Cytological
Applicant
CYTOCORE, INC.
414 NORTH ORLEAN
SUITE 502
CHICAGO, IL 60610 US
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Contact
RICHARD DOMANIK
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Regulation Number
884.4530
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Classification Product Code
HHT
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More FDA Info for this Product Code
Date Received
08/24/2007
Decision Date
01/30/2008
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
OB - Obstetrics/Gynecology
Review Advisory Committee
OB - Obstetrics/Gynecology
Statement / Summary / Purged Status
Summary
Type
Special
Reviewed By Third Party
N
Expedited Review
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