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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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More FDA Info for this Product Code
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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