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510(k) K160450

Pleurx Pleural Catheter System by Care Fusion — Product Code DWM

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 31, 2016
Date Received
February 18, 2016
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Apparatus, Suction, Patient Care
Device Class
Class II
Regulation Number
870.5050
Review Panel
AN
Submission Type

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