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FDA 510(k) Application Details - K211202
Device Classification Name
Endoscope, Neurological
More FDA Info for this Device
510(K) Number
K211202
Device Name
Endoscope, Neurological
Applicant
Stryker
5900 Optical Court
San Jose, CA 95138 US
Other 510(k) Applications for this Company
Contact
Jessie Duong
Other 510(k) Applications for this Contact
Regulation Number
882.1480
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Classification Product Code
GWG
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More FDA Info for this Product Code
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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