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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 K182160
Device Name 1688 Camera Control Unit ; 1688 AIM 4K Camera Head, C-Mount ; 1688 AIM 4K Camera Head with Integrated Coupler ; AIM 4K Coupler, 20mm, C-Mount ; L11 LED Light Source with AIM
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 Codes
Date Received08/09/2018
Decision Date 11/05/2018
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product Yes
Recalls CDRH Recalls