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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 K171965
Device Name Resection Electrodes with HF cable
Applicant
Olympus Winter & Ibe GmbH
Kuehnstrasse 61
Hamburg,  DE 22045
Applicant Contact Jan-Oliver Upmeier
Correspondent
Gyrus Acmi, Inc.
136 Tpke. Rd.
Southborough,  MA  01772
Correspondent Contact Dolan Mills
Regulation Number876.4300
Classification Product Code
FAS  
Subsequent Product Codes
FJL   HIH  
Date Received06/30/2017
Decision Date 09/28/2017
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
Recalls CDRH Recalls
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