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FDA 510(k), K991864, ROTAFLOW CENTRIFUGAL PUMP SYSTEM
FDA 510(k), K991864, ROTAFLOW CENTRIFUGAL PUMP SYSTEM
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510(K) Number: K991864
Device Name: ROTAFLOW CENTRIFUGAL PUMP SYSTEM
Manufacturer: KATHY JOHNSON
Device Classification Name: Pump, Blood, Cardiopulmonary Bypass, Non-Roller Type
Regulation Number: KFM
Classification Product Code: KXA
Date Received: 06/01/1999
Decision Date: 08/31/2000
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: Cardiovascular
Device Name: ROTAFLOW CENTRIFUGAL PUMP SYSTEM
Manufacturer: KATHY JOHNSON
Device Classification Name: Pump, Blood, Cardiopulmonary Bypass, Non-Roller Type
Regulation Number: KFM
Classification Product Code: KXA
Date Received: 06/01/1999
Decision Date: 08/31/2000
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: Cardiovascular
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- Delivery: Approximately 1 to 2 weeks when the FOIA office is operating at regular capacity
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