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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 K003667
Device Name REVEAL PLUS INSERTABLE LOOP RECORDER
Applicant
Medtronic Vascular
7000 Central Ave. NE
Minneapolis,  MN  55432 -3576
Applicant Contact STACEY P WESSMAN
Correspondent
Medtronic Vascular
7000 Central Ave. NE
Minneapolis,  MN  55432 -3576
Correspondent Contact STACEY P WESSMAN
Regulation Number870.2800
Classification Product Code
MXC  
Date Received11/28/2000
Decision Date 02/14/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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