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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 K220895
Device Name 1688 4K Camera Control Unit with Advanced Imaging Modality (1688010000), 1688 4K Pendulum Camera Head (1688310130)
Applicant
Stryker
5900 Optical Court
San Jose,  CA  95138
Applicant Contact Marlene Fraga
Correspondent
Stryker
5900 Optical Court
San Jose,  CA  95138
Correspondent Contact Marlene Fraga
Regulation Number876.1500
Classification Product Code
GCJ  
Subsequent Product Code
GWG  
Date Received03/28/2022
Decision Date 04/22/2022
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel General & Plastic Surgery
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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