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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 K032688
Device Name COLONOSIGHT MODEL 510B
Applicant
Sightline Technologies , Ltd.
Matam - Bldg. 20
Haifa,  IL 31905
Applicant Contact SHARON GOLDFARB-ALBAK
Correspondent
Sightline Technologies , Ltd.
Matam - Bldg. 20
Haifa,  IL 31905
Correspondent Contact SHARON GOLDFARB-ALBAK
Regulation Number876.1500
Classification Product Code
FDF  
Date Received08/29/2003
Decision Date 03/05/2004
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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