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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 K211332
Device Name D Camera Controller
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 Received05/03/2021
Decision Date 10/01/2021
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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