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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Colonoscope And Accessories, Flexible/Rigid
510(k) Number K220158
Device Name G-EYE System
Applicant
Smart Medical Systems Ltd.
5 HaNofar St.
Ra'anana,  IL 4366404
Applicant Contact Adva Yoselzon
Correspondent
Hogan Lovells US LLP
1735 Market Street, Floor 23
Philadelphia,  PA  19103
Correspondent Contact Janice Hogan
Regulation Number876.1500
Classification Product Code
FDF  
Date Received01/19/2022
Decision Date 04/11/2022
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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