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510(k) K072308

D131 PH.I.S.I.O DIDECO KIDS INFANT ARTERIAL FILTER WITH 40 MICRON SCREEN PHOSPHORYCHOLINE COATED by Sorin Group Italia S.R.L. — Product Code DTM

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 12, 2007
Date Received
August 17, 2007
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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