FDA 510(k) Application Details - K211202

Device Classification Name Endoscope, Neurological

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510(K) Number K211202
Device Name Endoscope, Neurological
Applicant Stryker
5900 Optical Court
San Jose, CA 95138 US
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Contact Jessie Duong
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Regulation Number 882.1480

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Classification Product Code GWG
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Date Received 04/22/2021
Decision Date 08/06/2021
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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