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GAMBRO LUNDIA 94-700 & SIGMA 800 HEMODIALYZERS

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K952342
510(k) Type
Traditional
Applicant
COBE RENAL CARE, INC.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
9/15/1995
Days to Decision
119 days
Submission Type
Statement

GAMBRO LUNDIA 94-700 & SIGMA 800 HEMODIALYZERS

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K952342
510(k) Type
Traditional
Applicant
COBE RENAL CARE, INC.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
9/15/1995
Days to Decision
119 days
Submission Type
Statement