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510(k) K093986

AF 620 PH.I.S.I.O., AF 640 PH.I.S.I.O. ARTERIAL FILTERS by Sorin Group Italia S.R.L. — Product Code DTM

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 22, 2010
Date Received
December 24, 2009
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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