FDA 510(k) Application Details - K003347

Device Classification Name Neurological Stereotaxic Instrument

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510(K) Number K003347
Device Name Neurological Stereotaxic Instrument
Applicant KINAMED, INC.
9229 CRANFORD DR.
POTOMAC, MD 20854 US
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Contact JOEL SLOMOFF
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Regulation Number 882.4560

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Classification Product Code HAW
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Date Received 10/25/2000
Decision Date 02/23/2001
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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