FDA 510(k) Application Details - K993568

Device Classification Name Endoscope, Neurological

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510(K) Number K993568
Device Name Endoscope, Neurological
Applicant MACHIDA ENDOSCOPE CO., LTD.
13-8, HONKOMAGOME 6-CHOME,
BUNKYO-KU
TOKYO JP
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Contact GENICHI KANAI
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Regulation Number 882.1480

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Classification Product Code GWG
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Date Received 10/21/1999
Decision Date 03/13/2000
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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