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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 K180583
Device Name LOGIC 4K CAMERA CONTROLLER, LOGIC 4K CAMERA HEAD
Applicant
Richard Wolf Medical Instruments Corporation
353 Corporate Woods Parkway
Vernon Hills,  IL  60061
Applicant Contact Michael Loiterman
Correspondent
Richard Wolf Medical Instruments Corporation
353 Corporate Woods Parkway
Vernon Hills,  IL  60061
Correspondent Contact Michael Loiterman
Regulation Number876.1500
Classification Product Code
FET  
Date Received03/05/2018
Decision Date 06/28/2018
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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