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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 K230605
Device Name 1788 4K Camera System with Advanced Imaging Modality
5900 Optical Court
San Jose,  CA  95138
Applicant Contact April Malmborg
5900 Optical Court
San Jose,  CA  95138
Correspondent Contact April Malmborg
Regulation Number876.1500
Classification Product Code
Subsequent Product Code
Date Received03/03/2023
Decision Date 03/31/2023
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