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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name unit, electrosurgical, endoscopic (with or without accessories)
510(k) Number K030194
Device Name XUES-41 ENDOSCOPIC ELECTROSURGICAL UNIT
Applicant
THE OLYMPUS OPTICAL CO.
ENDOSCOPE DIVISION
TWO CORPORATE CENTER DRIVE
MELVILLE,  NY  11747 -3157
Applicant Contact LAURA STORMS-TYLER
Correspondent
INTERTEK TESTING SERVICES
2307 EAST AURORA ROAD
UNIT B7
TWINSBURG,  OH  44087
Correspondent Contact DONALD JAMES SHERRATT
Regulation Number876.4300
Classification Product Code
KNS  
Date Received01/21/2003
Decision Date 03/24/2003
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Recalls CDRH Recalls
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