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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 K152092
Device Name Resection Electrodes
Applicant
Olympus Winter &Ibe GmbH
Kuehnstrasse 61
Hamburg,  DE 22045
Applicant Contact Katharina Schnackenburg
Correspondent
Gyrus Acmi, Inc.
136 Turnpike Rd.
Southborough,  MA  01772
Correspondent Contact Graham Baillie
Regulation Number876.4300
Classification Product Code
FAS  
Subsequent Product Codes
FJL   HIH  
Date Received07/28/2015
Decision Date 10/26/2015
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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