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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Electrosurgical, Cutting & Coagulation & Accessories
510(k) Number K203277
Device Name Electrosurgical Generator ESG-410, Foot Switches, PK Cutting Forceps
Applicant
Olympus Winter &Ibe GmbH
Kuehnstr, 61
Hamburg,  DE 22045
Applicant Contact Jan-Oliver Upmeier
Correspondent
Olympus Surgical Technologies America
118 Turnpike Rd.
Southborough,  MA  01772
Correspondent Contact Christina Flores
Regulation Number878.4400
Classification Product Code
GEI  
Date Received11/06/2020
Decision Date 04/28/2021
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
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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