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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Gastrointestinal Motility (Electrical)
510(k) Number K151086
Device Name ManoScan System
Applicant
GIVEN IMAGING LTD.
2 HACARMEL ST. NEW INDUSTRIAL PARK POB 258
YOQNEAM,  IL 20962
Applicant Contact HILLA DEBBY
Correspondent
GIVEN IMAGING LTD.
2 HACARMEL ST. NEW INDUSTRIAL PARK POB 258
YOQNEAM,  IL 20962
Correspondent Contact HILLA DEBBY
Regulation Number876.1725
Classification Product Code
FFX  
Date Received04/22/2015
Decision Date 04/28/2016
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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