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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Recorder, Event, Implantable Cardiac, (Without Arrhythmia Detection)
510(k) Number K994331
Device Name REVEAL PLUS INSERTABLE LOOP RECORDER SYSTEM, MODEL 9526 IMPLANTED RECORDER AND MODEL 6191 PATIENT ACTIVATOR
Applicant
Medtronic Vascular
4000 Lexington Ave. N.
Shoreview,  MN  55126
Applicant Contact NORA K HADDING
Correspondent
Medtronic Vascular
4000 Lexington Ave. N.
Shoreview,  MN  55126
Correspondent Contact NORA K HADDING
Regulation Number870.2800
Classification Product Code
MXC  
Date Received12/23/1999
Decision Date 01/21/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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