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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 K202592
Device Name Adavanced Imaging Modality System (1688 4K Camera System With Advanced Imaging Modality, L11 LED Light Source with Adavanced Imaging Modality)
Applicant
Stryker
5900 Optical Ct.
San Jose,  CA  95138
Applicant Contact Divya Sekar
Correspondent
Stryker
5900 Optical Ct.
San Jose,  CA  95138
Correspondent Contact Divya Sekar
Regulation Number876.1500
Classification Product Code
GCJ  
Subsequent Product Codes
FCS   FCW   OWN  
Date Received09/08/2020
Decision Date 10/08/2020
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
Predetermined Change
Control Plan Authorized		 No
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