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: 06/01/1999
Date Received: 08/31/2000
Decision Date: 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: 06/01/1999
Date Received: 08/31/2000
Decision Date: Substantially Equivalent (SESE)
Regulation Medical Specialty: Cardiovascular
- Status: Pending Fast-Track Request
- Delivery: Approximately 1 to 2 weeks
NOTE: This document is not currently in our library. Upon purchase, we will request the document from the FDA FOIA office. Learn more about Fast-Track Requests here.
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