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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Endoscopic Video Imaging System/Component, Gastroenterology-Urology
510(k) Number K032544
Device Name VP-1000; MED CAM 100; VP-3000A; MED CAM 300
Applicant
Mgb Endoskopische Gerate GmbH (Berlin)
Schwarzschildstrasse 6
Berlin,  DE 12489
Applicant Contact J TSCHEPE
Correspondent
Tuv America, Inc.
1775 Old Highway 8
New Brighton,  MN  55112 -1891
Regulation Number876.1500
Classification Product Code
FET  
Date Received08/18/2003
Decision Date 09/02/2003
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
Predetermined Change
Control Plan Authorized		 No
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