FDA 510(k) Application Details - K990683

Device Classification Name Neurological Stereotaxic Instrument

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510(K) Number K990683
Device Name Neurological Stereotaxic Instrument
Applicant AXON INSTRUMENTS, INC.
1101 CHESS DR.
FOSTER CITY, CA 94404-1102 US
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Contact ANDREW L BLATZ
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Regulation Number 882.4560

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Classification Product Code HAW
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Date Received 03/03/1999
Decision Date 11/03/1999
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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