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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 K172610
Device Name THUNDERBEAT 5 mm, 20 cm, Front-actuated Grip Type S, THUNDERBEAT 5 mm, 35 cm, Front-actuated Grip Type S, THUNDERBEAT 5 mm, 45 cm, Front-actuated Grip Type S
Applicant
Olympus Medical Systems Corp.
2951 Ishikawa-cho
Hachioji-Shi,  JP 192-8507
Applicant Contact Toshiyuki Nakajima
Correspondent
Gyrus ACMI Inc.
136 Turnpike Road
Southborough,  MA  01772
Correspondent Contact Christina Flores
Regulation Number878.4400
Classification Product Code
GEI  
Subsequent Product Code
LFL  
Date Received08/31/2017
Decision Date 04/17/2018
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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