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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name electrode, electrosurgical, active, urological
510(k) Number K210651
Device Name Resection Electrodes with HF cable
Applicant
Olympus Winter & Ibe GmbH
Kuehnstr. 61
Hamburg,  DE 22045
Applicant Contact Katharina Campbell
Correspondent
Olympus Surgical Technologies America
118 Turnpike Road
Southborough,  MA  01772
Correspondent Contact Christina Flores
Regulation Number876.4300
Classification Product Code
FAS  
Subsequent Product Codes
FJL   HIH  
Date Received03/04/2021
Decision Date 08/03/2021
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Obstetrics/Gynecology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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