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510(k) K120674

MAHURKAR ELITE ACUTE DUAL LUMEN CATHETER, ELITE ACUTE TRIPLE LUMEN CATHETER by Covidien — Product Code MPB

Clearance Details

Decision
SESK (Substantially Equivalent (kit))
Decision Date
April 4, 2012
Date Received
March 5, 2012
Clearance Type
Special
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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