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510(k) K093307

ASEPT PLEURAL DRAINAGE SYSTEM by Pfm Medical, Inc. — Product Code DWM

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 6, 2009
Date Received
October 22, 2009
Clearance Type
Traditional
Expedited Review
No
Third Party Review
Yes

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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  • K121849 — PLEURX PLEURAL CATHETER SYSTEM, PLEURX CATHETER ACCESS KIT, PLEURX CATHETER INSE (October 18, 2012)
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