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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Endoscopic Central Control Unit
510(k) Number K022270
Device Name MODIFICATION TO OLYMPUS INTEGRATED ENDOSURGERY SYSTEM ENDOALPHA
Applicant
OLYMPUS OPTICAL CO., LTD.
TWO CORPORATE CENTER DR.
MELVILLE,  NY  11747 -3157
Applicant Contact LAURA STORMS-TYLER
Correspondent
OLYMPUS OPTICAL CO., LTD.
TWO CORPORATE CENTER DR.
MELVILLE,  NY  11747 -3157
Correspondent Contact LAURA STORMS-TYLER
Regulation Number876.1500
Classification Product Code
ODA  
Date Received07/15/2002
Decision Date 08/14/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Radiology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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