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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 K042274
Device Name PSD-60/ENDOPLASMA
Applicant
Olympus Shirakawa Co., Ltd.
Two Corporate Center Dr.
Melville,  NY  11747
Applicant Contact TINA STEFFANIE-OAK
Correspondent
Intertek Testing Services
2307 E. Aurora Rd.
Unit B7
Twinsburg,  OH  44087
Regulation Number878.4400
Classification Product Code
GEI  
Date Received08/23/2004
Decision Date 02/22/2005
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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