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510(k) K030497

FRESENIUS NATURALYTE GRANUFLO DRY ACID CONCENTRATE 10XX SERIES, 24XX SERIES, 30XX SERIES by Fresenius Medical Care — Product Code KPO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 20, 2003
Date Received
February 19, 2003
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Dialysate Concentrate For Hemodialysis (Liquid Or Powder)
Device Class
Class II
Regulation Number
876.5820
Review Panel
GU
Submission Type

Other clearances by Fresenius Medical Care

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  • K141997 — CRIT-LINE IV SYSTEM (April 1, 2015)
  • K111639 — FRESENIUS 2008T HEMODIALYSIS MACHINE (October 21, 2011)
  • K023162 — FRESENIUS PUNCTUR-GUARD FISTULA NEEDLE SETS (March 20, 2003)
  • K022536 — \RESENIUS ACCESS FLOW RESERVING CONNECTORS, FRESENIUS STANDALONE ACCCES FLOW RES (October 30, 2002)
  • K994267 — FRESENIUS 2008K (March 16, 2000)

Other clearances for product code KPO

  • K253462 — NaturaLyte® Dry Bicarbonate Concentrate (08-4112-2) (January 29, 2026)
  • K252180 — Bicarby Dialysate RFP-404 (RFP-404-W); Bicarby Dialysate RFP-403 (RFP-403-W); Bi (September 9, 2025)
  • K243786 — Bicarby Dialysate RFP-402 (RFP-402-G); Bicarby Dialysate RFP-400 (RFP-400-G); Bi (April 4, 2025)
  • K240920 — HemoCare Bicarbonate Concentrate Set (BCS) (July 12, 2024)
  • K233950 — pureFLOW 402 (F00012067); pureFLOW 406 (F00012068); pureFLOW 401 (F00012069); pu (May 10, 2024)
  • K233213 — NxStage PureFlow Solution (January 18, 2024)
  • K233159 — pureFLOW 402, pureFLOW 400, pureFLOW 406, pureFLOW 401, pureFLOW 502, pureFLOW 5 (December 1, 2023)
  • K223431 — Citric Complete Liquid Citric Acid Concentrate (August 4, 2023)
  • K221652 — NIKKICART (March 3, 2023)
  • K202508 — Hemo-Lyte C Cartridge (August 12, 2022)