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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Instrument, Ultrasonic Surgical
510(k) Number K031710
Device Name OLYMPUS ULTRASONIC SURGICAL SYSTEM
Applicant
Aomori Olympus Co., Ltd.
2 Corporate Center Dr.
Melville,  NY  11747
Applicant Contact TINA STEFFANIE-OAK
Correspondent
Aomori Olympus Co., Ltd.
2 Corporate Center Dr.
Melville,  NY  11747
Correspondent Contact TINA STEFFANIE-OAK
Classification Product Code
LFL  
Date Received06/02/2003
Decision Date 08/29/2003
Decision Substantially Equivalent (SESE)
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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