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POLYFLUX 14L, 17L, 21L HEMODIALYZER/FILTER LABELED FOR SINGLE USE

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K040255
510(k) Type
Special
Applicant
GAMBRO RENAL PRODUCTS, INC.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
5/24/2004
Days to Decision
110 days
Submission Type
Summary

POLYFLUX 14L, 17L, 21L HEMODIALYZER/FILTER LABELED FOR SINGLE USE

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K040255
510(k) Type
Special
Applicant
GAMBRO RENAL PRODUCTS, INC.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
5/24/2004
Days to Decision
110 days
Submission Type
Summary