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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 K161204
Device Name ENDOCAM Flex HD Camera System 5521
Applicant
Richard Wolf Medical Instruments Corporation
353 Corporate Woods Pkwy.
Vernon Hills,  IL  60061
Applicant Contact MIKE LOITERMAN
Correspondent
Richard Wolf Medical Instruments Corporation
353 Corporate Woods Pkwy.
Vernon Hills,  IL  60061
Correspondent Contact MIKE LOITERMAN
Regulation Number876.1500
Classification Product Code
FET  
Date Received04/28/2016
Decision Date 01/11/2017
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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