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510(k) K121209

TERUMO PALL AL20X ARTERIAL FILTER by Terumo Cardiovascular Systems Corporation — Product Code DTM

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 8, 2012
Date Received
April 20, 2012
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Filter, Blood, Cardiopulmonary Bypass, Arterial Line
Device Class
Class II
Regulation Number
870.4260
Review Panel
CV
Submission Type

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