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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 K203682
Device Name Electrosurgical Generator ESG-400, Foot Switches, POWERSEAL Curved Jaw Sealer and Divider, Double Action
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 Number878.4400
Classification Product Code
GEI  
Date Received12/17/2020
Decision Date 05/17/2021
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
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