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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 K011098
Device Name REVEAL PLUS INSERTABLE LOOP RECORDER SYSTEM MODEL 9526 IMPLANTABLE RECORDER AND MODEL 6191 PATIENT ACTIVATOR
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 Received04/11/2001
Decision Date 05/04/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Special
Reviewed by Third Party No
Combination Product No
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