FDA 510(k) Application Details - K050973

Device Classification Name Neurological Stereotaxic Instrument

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510(K) Number K050973
Device Name Neurological Stereotaxic Instrument
Applicant MAKO SURGICAL CORP.
2901 SIMMS STREET
HOLLYWOOD, FL 33020 US
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Contact WILLIAM F TAPIA
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Regulation Number 882.4560

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Classification Product Code HAW
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Date Received 04/18/2005
Decision Date 05/17/2005
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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