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510(k) K130493

CAPIOX RX05 HOLLOW FIBER OXYGENATOR/RESERVOIR by Terumo Corporation — Product Code DTZ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 13, 2013
Date Received
February 26, 2013
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Oxygenator, Cardiopulmonary Bypass
Device Class
Class II
Regulation Number
870.4350
Review Panel
CV
Submission Type

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