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FDA 510(k) Application Details - K052851
Device Classification Name
Neurological Stereotaxic Instrument
More FDA Info for this Device
510(K) Number
K052851
Device Name
Neurological Stereotaxic Instrument
Applicant
MAKO SURGICAL CORP.
2901 SIMMS STREET
HOLLYWOOD, FL 33020 US
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Contact
WILLIAM F TAPIA
Other 510(k) Applications for this Contact
Regulation Number
882.4560
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Classification Product Code
HAW
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More FDA Info for this Product Code
Date Received
10/11/2005
Decision Date
11/18/2005
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
NE - Neurology
Review Advisory Committee
NE - Neurology
Statement / Summary / Purged Status
Summary
Type
Special
Reviewed By Third Party
N
Expedited Review
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