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FDA 510(k) Application Details - K063607
Device Classification Name
Neurological Stereotaxic Instrument
More FDA Info for this Device
510(K) Number
K063607
Device Name
Neurological Stereotaxic Instrument
Applicant
MAZOR SURGICAL TECHNOLOGIES LTD.
20 HATA'AS ST.
KFAR SABA 44425 IL
Other 510(k) Applications for this Company
Contact
AHAVA STEIN
Other 510(k) Applications for this Contact
Regulation Number
882.4560
More FDA Info for this Regulation Number
Classification Product Code
HAW
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
12/04/2006
Decision Date
08/23/2007
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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