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510(k) K040301

GAMCATH HIGH FLOW CATHETER, REF: GDHK 13XX A by Gambro Renal Products — Product Code MPB

Clearance Details

Decision
SESK (Substantially Equivalent (kit))
Decision Date
November 1, 2004
Date Received
February 9, 2004
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

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

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