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FDA 510(k) Application Details - K093904
Device Classification Name
Instrument, Manual, Specialized Obstetric-Gynecologic
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510(K) Number
K093904
Device Name
Instrument, Manual, Specialized Obstetric-Gynecologic
Applicant
GLENVEIGH SURGICAL, LLC
717 LAKEGLEN DRIVE
SUWANEE, GA 30024 US
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Contact
PENNY NORTHCUTT
Other 510(k) Applications for this Contact
Regulation Number
884.4530
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Classification Product Code
KNA
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
12/22/2009
Decision Date
04/14/2010
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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