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510(k) K103469

STOCKERT AIR PURGE CONTROL SYSTEM MODEL 23-45-05 by Sorin Group Deutschland GmbH — Product Code KRL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 18, 2011
Date Received
November 24, 2010
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Detector, Bubble, Cardiopulmonary Bypass
Device Class
Class II
Regulation Number
870.4205
Review Panel
CV
Submission Type

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