FDA 510(k) Application Details - K022074

Device Classification Name Neurological Stereotaxic Instrument

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510(K) Number K022074
Device Name Neurological Stereotaxic Instrument
Applicant I.Z.I. CORP.
7020 TUDSBURY RD.
BALTIMORE, MD 21244 US
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Contact HELEN ZINREICH
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Regulation Number 882.4560

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Classification Product Code HAW
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Date Received 06/26/2002
Decision Date 08/13/2002
Decision SESE - SUBST EQUIV
Classification Advisory Committee NE - Neurology
Review Advisory Committee NE - Neurology
Statement / Summary / Purged Status Statement
Type Traditional
Reviewed By Third Party N
Expedited Review



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