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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 K031305
Device Name OLYMPUS ULTRASONIC SURGICAL SYSTEM
Applicant
Olympus Optical Co., Ltd.
Two Corporate Center Dr.
Melville,  NY  11747
Applicant Contact TINA STEFFANIE-OAK
Correspondent
Olympus Optical Co., Ltd.
Two Corporate Center Dr.
Melville,  NY  11747
Correspondent Contact TINA STEFFANIE-OAK
Classification Product Code
LFL  
Date Received04/24/2003
Decision Date 09/23/2003
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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