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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 K230216
Device Name 1688 4K Camera Control Unit with Advanced Imaging Modality (1688010000)
5900 Optical Ct
San Jose,  CA  95138
Applicant Contact Michelle Stephens
5900 Optical Ct
San Jose,  CA  95138
Correspondent Contact Michelle Stephens
Regulation Number876.1500
Classification Product Code
Subsequent Product Code
Date Received01/26/2023
Decision Date 02/23/2023
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