FDA 510(k) Application Details - K992721

Device Classification Name Neurological Stereotaxic Instrument

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510(K) Number K992721
Device Name Neurological Stereotaxic Instrument
Applicant RADIONICS, INC.
22 TERRY AVE.
BURLINGTON, MA 01803-2516 US
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Contact KEVIN J O'CONNELL
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Regulation Number 882.4560

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Classification Product Code HAW
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Date Received 08/13/1999
Decision Date 09/10/1999
Decision SESE - SUBST EQUIV
Classification Advisory Committee NE - Neurology
Review Advisory Committee NE - Neurology
Statement / Summary / Purged Status Summary
Type Special
Reviewed By Third Party N
Expedited Review



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