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510(k) K140884

SYMETREX LONG TERM HEMODIALYSIS CATHETER by Phase One Medical — Product Code MSD

Clearance Details

Decision
SESK (Substantially Equivalent (kit))
Decision Date
November 26, 2014
Date Received
April 7, 2014
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Catheter, Hemodialysis, Implanted
Device Class
Class II
Regulation Number
876.5540
Review Panel
GU
Submission Type

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