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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 STREET, STE 213
BEIT HAPA'AMON, BOX 124
KFAR SABA,  IL 44425
Applicant Contact AHAVA STEIN
Correspondent
SMART MEDICAL SYSTEMS, LTD.
20 HATA'AS STREET, STE 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
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