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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name detector and alarm, arrhythmia
510(k) Number K160809
Device Name Reveal LINQ
Applicant
MEDTRONIC, INC.
8200 CORAL SEA ST NW
mounds view,  MN  55112
Applicant Contact dianna l johannson
Correspondent
MEDTRONIC, INC.
8200 CORAL SEA ST NW
mounds view,  MN  55112
Correspondent Contact dianna l johannson
Regulation Number870.1025
Classification Product Code
DSI  
Date Received03/24/2016
Decision Date 05/26/2016
Decision substantially equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
summary summary
Type Special
Reviewed by Third Party No
Combination Product No
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