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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 K102616
Device Name NAVIAID BALLOON GUIDED COLONOSCOPY (BGC) DEVICE
Applicant
SMART MEDICAL SYSTEMS, LTD.
10 HAYETSIRA STREET
RAANANA,  IL 43663
Applicant Contact ADVA YOSELZON
Correspondent
SMART MEDICAL SYSTEMS, LTD.
10 HAYETSIRA STREET
RAANANA,  IL 43663
Correspondent Contact ADVA YOSELZON
Regulation Number876.1500
Classification Product Code
FDF  
Date Received09/10/2010
Decision Date 12/30/2010
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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