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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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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