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FDA 510(k), K152938, DBB-06 Hemodialysis Delivery System
FDA 510(k), K152938, DBB-06 Hemodialysis Delivery System
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510(K) Number: K152938
Device Name: DBB-06 Hemodialysis Delivery System
Manufacturer: SEIYA RAIJYU
Device Classification Name: Dialyzer, High Permeability With Or Without Sealed Dialysate System
Regulation Number: KDI
Classification Product Code: KXA
Date Received: 10/05/2015
Decision Date: 03/18/2016
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: Gastroenterology/Urology
Device Name: DBB-06 Hemodialysis Delivery System
Manufacturer: SEIYA RAIJYU
Device Classification Name: Dialyzer, High Permeability With Or Without Sealed Dialysate System
Regulation Number: KDI
Classification Product Code: KXA
Date Received: 10/05/2015
Decision Date: 03/18/2016
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: Gastroenterology/Urology
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- Status: Pending Fast-Track Request
- Delivery: Approximately 1 to 2 weeks when the FOIA office is operating at regular capacity
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