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510(k) K060651

PROXIS SYSTEM, MODEL EPS101 by St Jude Medical — Product Code NFA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 13, 2006
Date Received
March 13, 2006
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Temporary Coronary Saphenous Vein Bypass Graft For Embolic Protection
Device Class
Class II
Regulation Number
870.1250
Review Panel
CV
Submission Type

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