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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name endoscope, neurological
510(k) Number K211202
Device Name 1688 4K Camera System, L11 LED Light Source with AIM, AIM SafeLight Cable, Precision S 4K Sinuscopes
Applicant
Stryker
5900 Optical Court
San Jose,  CA  95138
Applicant Contact Jessie Duong
Correspondent
Stryker
5900 Optical Court
San Jose,  CA  95138
Correspondent Contact Jessie Duong
Regulation Number882.1480
Classification Product Code
GWG  
Subsequent Product Codes
FCS   FCW   GCJ   OWN  
Date Received04/22/2021
Decision Date 08/06/2021
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product Yes
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