FDA 510(k) Application Details - K093508

Device Classification Name Cannula, Suction, Uterine

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510(K) Number K093508
Device Name Cannula, Suction, Uterine
Applicant WOMANCARE GLOBAL
300 MARKET ST. SUITE 134
CHAPEL HILL, NC 27516 US
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Contact Susanne Parks
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Regulation Number 884.5070

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Classification Product Code HGH
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Date Received 11/12/2009
Decision Date 03/04/2010
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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