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Optiflux Enexa F500 Dialyzer

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K192928
510(k) Type
Traditional
Applicant
Fresenius Medical Care Reanal Therapies Group LLC
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
7/9/2020
Days to Decision
266 days
Submission Type
Summary

Optiflux Enexa F500 Dialyzer

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K192928
510(k) Type
Traditional
Applicant
Fresenius Medical Care Reanal Therapies Group LLC
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
7/9/2020
Days to Decision
266 days
Submission Type
Summary