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FDA 510(k) Application Details - K091692
Device Classification Name
Cover, Burr Hole
More FDA Info for this Device
510(K) Number
K091692
Device Name
Cover, Burr Hole
Applicant
AESCULAP, INC.
3773 Corporate Parkway
Center Valley, PA 18034 US
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Contact
LISA M BOYLE
Other 510(k) Applications for this Contact
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
06/10/2009
Decision Date
08/12/2010
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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