FDA 510(k) Application Details - K030764

Device Classification Name Neurological Stereotaxic Instrument

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510(K) Number K030764
Device Name Neurological Stereotaxic Instrument
Applicant Z-KAT, INC.
2901 SIMMS ST.
HOLLYWOOD, FL 33020 US
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Contact CHRISTINA VANCE
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Regulation Number 882.4560

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Classification Product Code HAW
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Date Received 03/11/2003
Decision Date 04/24/2003
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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