FDA 510(k) Application Details - K984298

Device Classification Name Neurological Stereotaxic Instrument

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510(K) Number K984298
Device Name Neurological Stereotaxic Instrument
Applicant Z-KAT, INC.
11645 BISCAYNE BLVD.
SUITE 304
MIAMI, FL 33181 US
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Contact RONY ABOVITZ
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Regulation Number 882.4560

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Classification Product Code HAW
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Date Received 12/02/1998
Decision Date 06/23/1999
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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