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510(k) K992559

HOLLOW FIBER MEMBRANE OYGENATOR QUADROX HMO 1010 by Jostra Bentley — Product Code DTZ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 20, 1999
Date Received
July 30, 1999
Clearance Type
Traditional
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

Other clearances by Jostra Bentley

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