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FDA 510(k) Application Details - K140309
Device Classification Name
Cover, Burr Hole
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510(K) Number
K140309
Device Name
Cover, Burr Hole
Applicant
OSSDSIGN AB
808 WILLIAMSON ST. SUITE 402
MADISON, WI 53703 US
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DAVID WEISSBURG
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Regulation Number
882.5250
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Classification Product Code
GXR
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More FDA Info for this Product Code
Date Received
02/07/2014
Decision Date
10/03/2014
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
NE - Neurology
Review Advisory Committee
NE - Neurology
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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