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FDA 510(k), K031099, SORB+HISORB+CARTRIDGE
FDA 510(k), K031099, SORB+HISORB+CARTRIDGE
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510(K) Number: K031099
Device Name: SORB+HISORB+CARTRIDGE
Manufacturer: RENAL SOLUTIONS, INC.
Device Classification Name: System, Dialysate Delivery, Sorbent Regenerated
Regulation Number: 876.5600
Classification Product Code: FKT
Date Received: 04/07/2003
Decision Date: 09/17/2003
Regulation Medical Specialty: Gastroenterology/Urology
Device Name: SORB+HISORB+CARTRIDGE
Manufacturer: RENAL SOLUTIONS, INC.
Device Classification Name: System, Dialysate Delivery, Sorbent Regenerated
Regulation Number: 876.5600
Classification Product Code: FKT
Date Received: 04/07/2003
Decision Date: 09/17/2003
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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