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PHOENIX HEMODIALYSIS DELIVERY SYSTEM, VERSION 3.35

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K070643
510(k) Type
Traditional
Applicant
GAMBRO, INC.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
11/2/2007
Days to Decision
239 days
Submission Type
Summary

PHOENIX HEMODIALYSIS DELIVERY SYSTEM, VERSION 3.35

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K070643
510(k) Type
Traditional
Applicant
GAMBRO, INC.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
11/2/2007
Days to Decision
239 days
Submission Type
Summary