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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 K091206
Device Name SLEUTH AT IMPLANTABLE CARDIAC MONITORING SYSTEM-6 AND 8CM ANTENNA, PERSONAL DIAGNOSTIC MANAGER(PDM) ACCESSORY KIT, MODEL
Applicant
TRANSOMA MEDICAL
4211 LEXINGTON AVE., NORTH
SUITE #2244
ST. PAUL,  MN  55126 -6164
Applicant Contact LISA STONE
Correspondent
TRANSOMA MEDICAL
4211 LEXINGTON AVE., NORTH
SUITE #2244
ST. PAUL,  MN  55126 -6164
Correspondent Contact LISA STONE
Regulation Number870.2800
Classification Product Code
MXC  
Date Received04/24/2009
Decision Date 05/18/2009
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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