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510(k) K121849

PLEURX PLEURAL CATHETER SYSTEM, PLEURX CATHETER ACCESS KIT, PLEURX CATHETER INSERTION STYLET, PLEURX INTEGRAL VALVED PEE by Care Fusion — Product Code DWM

Clearance Details

Decision: SESE (Substantially Equivalent)
Decision Date: October 18, 2012
Date Received: June 25, 2012
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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