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510(k) K141965

PLEURX PLEURAL CATHETER SYSTEM, PLEURX CATHETER ACCESS KIT by Care Fusion — Product Code DWM

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 2, 2015
Date Received
July 21, 2014
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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