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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 K071655
Device Name REVEAL DX INSERTABLE CARDIAC MONITOR, REVEAL PATIENT ASSISTANT, MODEL(S) 9528,9538
Applicant
Medtronic, Inc.
8200 Coral Sea St. NW
Mounds View,  MN  55112
Applicant Contact MICHELLE NIVALA
Correspondent
Medtronic, Inc.
8200 Coral Sea St. NW
Mounds View,  MN  55112
Correspondent Contact MICHELLE NIVALA
Regulation Number870.1025
Classification Product Code
DSI  
Date Received06/18/2007
Decision Date 11/21/2007
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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