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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 K023767
Device Name UES-30 ELECTROSURGICAL UNIT AND IT'S ASSOCIATED ACCESSORIES
Applicant
The Olympus Optical Co.
Two Corporate Dr.
Melville,  NY  11747
Applicant Contact LAURA STORMS-TYLER
Correspondent
The Olympus Optical Co.
Two Corporate Dr.
Melville,  NY  11747
Correspondent Contact LAURA STORMS-TYLER
Regulation Number878.4400
Classification Product Code
GEI  
Date Received11/12/2002
Decision Date 11/29/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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