FDA 510(k) Application Details - K992843

Device Classification Name Neurological Stereotaxic Instrument

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510(K) Number K992843
Device Name Neurological Stereotaxic Instrument
Applicant OHIO MEDICAL INSTRUMENT CO., INC.
4900 CHARLEMAR DR.
CINCINNATI, OH 45227 US
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Contact KENNETH B MILLER
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Regulation Number 882.4560

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Classification Product Code HAW
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Date Received 08/24/1999
Decision Date 11/02/1999
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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