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Optiflux Series of Dialyzers F160NR, F180NR, F200NR

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K203062
510(k) Type
Traditional
Applicant
Fresenius Medical Care Renal Therapies Group, LLC
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
12/28/2020
Days to Decision
80 days
Submission Type
Summary

Optiflux Series of Dialyzers F160NR, F180NR, F200NR

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K203062
510(k) Type
Traditional
Applicant
Fresenius Medical Care Renal Therapies Group, LLC
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
12/28/2020
Days to Decision
80 days
Submission Type
Summary