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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 K970184
Device Name OLYMPUS UES-20 ELECTROSURGICAL SYSTEM AND ITS ASSOCIATED ACCESSORIES
Applicant
Olympus America, Inc.
Two Corporate Center Dr.
Melville,  NY  11747
Applicant Contact SUBHASH R PATEL
Correspondent
Olympus America, Inc.
Two Corporate Center Dr.
Melville,  NY  11747
Correspondent Contact SUBHASH R PATEL
Regulation Number878.4400
Classification Product Code
GEI  
Date Received01/17/1997
Decision Date 04/11/1997
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
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