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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Endoscopic Ultrasound System, Gastroenterology-Urology
510(k) Number K031347
Device Name ULTRASONIC GASTROVIDEOSCOPE, TYPE UC160P-AT8 AND UCT160-AT8
Applicant
Olympus Optical Co., Ltd.
Two Corporate Center Dr.
Melville,  NY  11747
Applicant Contact LAURA STORMS-TYLER
Correspondent
Tuv America, Inc.
1775 Old Hwy. 8
New Brighton,  MN  55112
Correspondent Contact LAURA DANIELSON
Regulation Number876.1500
Classification Product Code
ODG  
Subsequent Product Codes
FDS   FET  
Date Received04/29/2003
Decision Date 05/09/2003
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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