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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 K123429
Device Name OLYMPUS ENERGY POWER SYSTEM (EPS)
Applicant
GYRUS ACMI, INC.
136 TURNPIKE RD.
SOUTHBOROUGH,  MA  01772
Applicant Contact DOLAN MILLS
Correspondent
GYRUS ACMI, INC.
136 TURNPIKE RD.
SOUTHBOROUGH,  MA  01772
Correspondent Contact DOLAN MILLS
Regulation Number878.4400
Classification Product Code
GEI  
Date Received11/07/2012
Decision Date 04/05/2013
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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