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FDA 510(k), K811170, D-3160 SORBENT CARTRIDGE
FDA 510(k), K811170, D-3160 SORBENT CARTRIDGE
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510(K) Number: K811170
Device Name: D-3160 SORBENT CARTRIDGE
Manufacturer:
Device Classification Name: System, Dialysate Delivery, Sorbent Regenerated
Regulation Number: FKT
Classification Product Code: 04/28/1981
Date Received: 07/31/1981
Decision Date: Substantially Equivalent (SESE)
Regulation Medical Specialty: Gastroenterology/Urology
Device Name: D-3160 SORBENT CARTRIDGE
Manufacturer:
Device Classification Name: System, Dialysate Delivery, Sorbent Regenerated
Regulation Number: FKT
Classification Product Code: 04/28/1981
Date Received: 07/31/1981
Decision Date: Substantially Equivalent (SESE)
Regulation Medical Specialty: Gastroenterology/Urology
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- 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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