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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 K052413
Device Name TUNA SYSTEM, MODELS 8909, 8929, 8930, 8934
Applicant
Medtronic Vascular
4000 Lexington Ave. N
Shoreview,  MN  55126 -2983
Applicant Contact JULIE GOODE
Correspondent
Underwriters Laboratories, Inc.
1285 Walt Whitman Rd.
Melville,  NY  11747
Correspondent Contact CASEY CONRY
Regulation Number876.4300
Classification Product Code
KNS  
Subsequent Product Code
GEI  
Date Received09/02/2005
Decision Date 11/17/2005
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
Recalls CDRH Recalls
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