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510(k) K151911

WorkMate Claris System, WorkMate Claris System Display Plus by St Jude Medical — Product Code DQK

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 22, 2015
Date Received
July 13, 2015
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Computer, Diagnostic, Programmable
Device Class
Class II
Regulation Number
870.1425
Review Panel
CV
Submission Type

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