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FDA 510(k), K103762, SORIN C5 SYSTEM; 85/C5 MAST ROLLER PUMP SYSTEM 150(1X RP 150 AND CONTROL PANEL WITH CONNECTING CABLES); S5/C5 MAST ROLLE
FDA 510(k), K103762, SORIN C5 SYSTEM; 85/C5 MAST ROLLER PUMP SYSTEM 150(1X RP 150 AND CONTROL PANEL WITH CONNECTING CABLES); S5/C5 MAST ROLLE
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510(K) Number: K103762
Device Name: SORIN C5 SYSTEM; 85/C5 MAST ROLLER PUMP SYSTEM 150(1X RP 150 AND CONTROL PANEL WITH CONNECTING CABLES); S5/C5 MAST ROLLE
Manufacturer: ROSINA ROBINSON, RN, MED, RAC
Device Classification Name: Console, Heart-Lung Machine, Cardiopulmonary Bypass
Regulation Number: DTQ
Classification Product Code: KXA
Date Received: 12/23/2010
Decision Date: 01/20/2011
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: Cardiovascular
Device Name: SORIN C5 SYSTEM; 85/C5 MAST ROLLER PUMP SYSTEM 150(1X RP 150 AND CONTROL PANEL WITH CONNECTING CABLES); S5/C5 MAST ROLLE
Manufacturer: ROSINA ROBINSON, RN, MED, RAC
Device Classification Name: Console, Heart-Lung Machine, Cardiopulmonary Bypass
Regulation Number: DTQ
Classification Product Code: KXA
Date Received: 12/23/2010
Decision Date: 01/20/2011
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: Cardiovascular
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