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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheters, Transluminal Coronary Angioplasty, Percutaneous
510(k) Number K103095
Device Name SPRINTER LEGEND 1.25MM RX AND SPRINTER LEGEND 1.25MM OTW BALLOON
Applicant
Medtronic, Ireland
3576 Unocal Place
Santa Rosa,  CA  95403
Applicant Contact GERARDINE FINN
Correspondent
Medtronic, Ireland
3576 Unocal Place
Santa Rosa,  CA  95403
Correspondent Contact GERARDINE FINN
Regulation Number870.5100
Classification Product Code
LOX  
Date Received10/08/2010
Decision Date 10/22/2010
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Clinical Trials NCT00961311
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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