FDA 510(k) Application Details - K955598

Device Classification Name Endoscope, Neurological

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510(K) Number K955598
Device Name Endoscope, Neurological
Applicant CLARUS MEDICAL SYSTEMS, INC.
1000 BOONE AVENUE NORTH
#100
MINNEAPOLIS, MN 55427-8656 US
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Contact JOHN VANDEN HOEK
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Regulation Number 882.1480

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Classification Product Code GWG
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Date Received 12/08/1995
Decision Date 02/06/1996
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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