Last synced on 9 December 2022 at 11:04 pm

POLYFLUX FAMILY HEMODIALYZER/FILTER LABELED FOR SINGLE AND MULTIPLE USE, MODELS 14L, 17L, 21L, 140H, 170H, 210H,6LR, 8LR

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K043342
510(k) Type
Traditional
Applicant
GAMBRO RENAL PRODUCTS
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
5/27/2005
Days to Decision
172 days
Submission Type
Summary

POLYFLUX FAMILY HEMODIALYZER/FILTER LABELED FOR SINGLE AND MULTIPLE USE, MODELS 14L, 17L, 21L, 140H, 170H, 210H,6LR, 8LR

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K043342
510(k) Type
Traditional
Applicant
GAMBRO RENAL PRODUCTS
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
5/27/2005
Days to Decision
172 days
Submission Type
Summary