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510(k) K103468

STOCKERT CENTRIFUGAL PUMP (SCP PLUS) (COMPLETE) OR (FOR S5/C5 SYSTEMS) by Sorin Group Deutschland GmbH — Product Code DWA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 20, 2011
Date Received
November 24, 2010
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Control, Pump Speed, Cardiopulmonary Bypass
Device Class
Class II
Regulation Number
870.4380
Review Panel
CV
Submission Type

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  • K101046 — STOCKERT S5 SYSTEM AND GAS BLENDER AND SORIN C5 SYSTEM (December 9, 2010)
  • K093882 — SORIN C5 SYSTEM MODEL 58-00-00 (January 15, 2010)

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