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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 K230588
Device Name Aer-O-Scope Colonoscope System
Applicant
Gi View , Ltd.
5 Shoham St.
Ramat Gan,  IL 5251001
Applicant Contact Sharon Goldfarb
Correspondent
Covington & Burling, Llp
One City Center, 850 Tenth St., NW
Washington, Dc,  DC  20001 -4956
Correspondent Contact Kristin Davenport
Regulation Number876.1500
Classification Product Code
FDF  
Date Received03/02/2023
Decision Date 08/17/2023
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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