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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 K200310
Device Name 1688 Pendulum 4K Camera Head with Integrated Coupler, 1688 4K Camera Control Unit with Advanced Imaging Modality
Applicant
Stryker
5900 Optical Ct
San Jose,  CA  95138
Applicant Contact April Malmborg
Correspondent
Stryker
5900 Optical Ct
San Jose,  CA  95138
Correspondent Contact April Malmborg
Regulation Number876.1500
Classification Product Code
GCJ  
Date Received02/06/2020
Decision Date 03/06/2020
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
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