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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 K192103
Device Name Thunderbeat Open Fine Jaw Type X Hand Instrument
Applicant
Olympus Medical Systems Corp.
2951 Ishikawa-Cho
Hachiochi-Shi,  JP 192-8507
Applicant Contact Toshiyuki Nakajima
Correspondent
Gyrus Acmi, Inc.
136 Turnpike Rd.
Southborough,  MA  01772
Correspondent Contact Christina Flores
Regulation Number878.4400
Classification Product Code
GEI  
Subsequent Product Code
LFL  
Date Received08/05/2019
Decision Date 05/11/2020
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel Ear Nose & Throat
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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