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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 K210392
Device Name WorkMate Claris System
Applicant
Abbott
One St. Jude Medical Drive
St. Paul,  MN  55117
Applicant Contact Ed Sandberg
Correspondent
Abbott
One St. Jude Medical Drive
St. Paul,  MN  55117
Correspondent Contact Ed Sandberg
Regulation Number870.1425
Classification Product Code
DQK  
Date Received02/10/2021
Decision Date 03/11/2021
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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