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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Endoscopic Video Imaging System/Component, Gastroenterology-Urology
510(k) Number K090800
Device Name VS-100 ILLUMINATION AND IMAGING SYSTEM
Applicant
Schoelly Imaging, Inc.
100 Indian Head Rd.
Framingham,  MA  01701
Applicant Contact KEN SPECTOR
Correspondent
Intertek Testing Services
2307 E. Aurora Rd.
Unit B7
Twinsburg,  OH  44087
Correspondent Contact DANIEL W LEHTONEN
Regulation Number876.1500
Classification Product Code
FET  
Date Received03/24/2009
Decision Date 05/18/2009
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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