FDA 510(k) Application Details - K062433

Device Classification Name Spatula, Cervical, Cytological

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510(K) Number K062433
Device Name Spatula, Cervical, Cytological
Applicant DIAMICS, INC.
SIX HAMILTON LANDING SUITE 200
NOVATO, CA 94949 US
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Contact PETER GOMBRICH
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Regulation Number 884.4530

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Classification Product Code HHT
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Date Received 08/21/2006
Decision Date 03/16/2007
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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