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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 K911485
Device Name COLOR VIDEO CAMERA
Applicant
United States Endoscopy Group, Inc.
7123 Industrial Park Blvd.
Mentor,  OH  44060
Applicant Contact DEAN SECREST
Correspondent
United States Endoscopy Group, Inc.
7123 Industrial Park Blvd.
Mentor,  OH  44060
Correspondent Contact DEAN SECREST
Regulation Number876.1500
Classification Product Code
FET  
Date Received04/04/1991
Decision Date 08/14/1991
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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