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FDA 510(k), K812869, D-3260 SORBENT CARTRIDGE
FDA 510(k), K812869, D-3260 SORBENT CARTRIDGE
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510(K) Number: K812869
Device Name: D-3260 SORBENT CARTRIDGE
Manufacturer:
Device Classification Name: System, Dialysate Delivery, Sorbent Regenerated
Regulation Number: FKT
Classification Product Code: KXA
Date Received: 10/14/1981
Decision Date: 12/08/1981
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: Gastroenterology/Urology
Device Name: D-3260 SORBENT CARTRIDGE
Manufacturer:
Device Classification Name: System, Dialysate Delivery, Sorbent Regenerated
Regulation Number: FKT
Classification Product Code: KXA
Date Received: 10/14/1981
Decision Date: 12/08/1981
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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