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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Computer, Diagnostic, Programmable
510(k) Number K151911
FOIA Releasable 510(k) K151911
Device Name WorkMate Claris System, WorkMate Claris System Display Plus
Applicant
St Jude Medical
One St. Jude Medical Dr.
St. Paul,  MN  55117
Applicant Contact MELISSA FRANK
Correspondent
St Jude Medical
One St. Jude Medical Dr.
St. Paul,  MN  55117
Correspondent Contact MELISSA FRANK
Regulation Number870.1425
Classification Product Code
DQK  
Date Received07/13/2015
Decision Date 10/22/2015
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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