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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 K161791
Device Name Aer-O-Scope Colonoscope System
Applicant
GI View Ltd.
5 Shoham St.
Ramat Gan,  IL 5251001
Applicant Contact Sharon Goldfarb
Correspondent
Goodwin Procter LLP
901 New York Avenue, NW
Washington,  DC  20001
Correspondent Contact Mark Heller
Regulation Number876.1500
Classification Product Code
FDF  
Date Received06/29/2016
Decision Date 08/11/2016
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
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