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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 K212808
Device Name Logic Hd camera head green, System green
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  
Subsequent Product Code
GCJ  
Date Received09/03/2021
Decision Date 06/14/2022
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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