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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 K032066
Device Name SONOSURG SYSTEM
Applicant
THE OLYMPUS OPTICAL CO.
ENDOSCOPE DIVISION
TWO CORPORATE CENTER DRIVE
MELVILLE,  NY  11747 -3157
Applicant Contact TINA STEFFANIE-OAK
Correspondent
THE OLYMPUS OPTICAL CO.
ENDOSCOPE DIVISION
TWO CORPORATE CENTER DRIVE
MELVILLE,  NY  11747 -3157
Correspondent Contact TINA STEFFANIE-OAK
Classification Product Code
LFL  
Date Received07/03/2003
Decision Date 10/03/2003
Decision Substantially Equivalent (SESE)
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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