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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Laparoscope, General & Plastic Surgery
510(k) Number K214046
Device Name 780 nm 1688 4K Camera System, 780 nm L11 LED Light Source with AIM and Safelight Cable
Applicant
Stryker
5900 Optical Court
San Jose,  CA  95138
Applicant Contact Michelle Hughes
Correspondent
Stryker
5900 Optical Court
San Jose,  CA  95138
Correspondent Contact Michelle Hughes
Regulation Number876.1500
Classification Product Code
GCJ  
Subsequent Product Codes
FCS   FCW   GWG   OWN  
Date Received12/27/2021
Decision Date 05/25/2022
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product Yes
Predetermined Change
Control Plan Authorized		 No
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