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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Enteroscope And Accessories
510(k) Number K060923
Device Name NAVIAID BGE DEVICE, MODEL 21-001
Applicant
Smart Medical Systems , Ltd.
20 Hata'As St., Suite 213
Beit Hapa'Amon, Box 124
Kfar Saba,  IL 44425
Applicant Contact AHAVA STEIN
Correspondent
Smart Medical Systems , Ltd.
20 Hata'As St., Suite 213
Beit Hapa'Amon, Box 124
Kfar Saba,  IL 44425
Correspondent Contact AHAVA STEIN
Regulation Number876.1500
Classification Product Code
FDA  
Subsequent Product Code
KNT  
Date Received04/04/2006
Decision Date 08/15/2006
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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