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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 K132703
Device Name THUNDERBEAT
Applicant
OLYMPUS MEDICAL SYSTEMS CORP.
136 TURNPIKE ROAD
REGULATORY AFFAIRS DIVISION
SOUTHBOROUGH,  MA  01772
Applicant Contact GRAHAM BAILLIE
Correspondent
OLYMPUS MEDICAL SYSTEMS CORP.
136 TURNPIKE ROAD
REGULATORY AFFAIRS DIVISION
SOUTHBOROUGH,  MA  01772
Correspondent Contact GRAHAM BAILLIE
Regulation Number878.4400
Classification Product Code
GEI  
Subsequent Product Code
LFL  
Date Received08/29/2013
Decision Date 05/19/2014
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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