FDA 510(k) Application Details - K052623

Device Classification Name Neurological Stereotaxic Instrument

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510(K) Number K052623
Device Name Neurological Stereotaxic Instrument
Applicant MEDTRONIC NAVIGATION, INC.
826 COAL CREEK CIRCLE
LOUSVILLE, CO 80027 US
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Contact TINA DREILING
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Regulation Number 882.4560

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Classification Product Code HAW
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Date Received 09/23/2005
Decision Date 03/02/2006
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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