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HOSPAL BICART RETROFIT KIT NA/MONIT S GS HEMODIAL

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K904967
510(k) Type
Traditional
Applicant
GAMBRO-HOSP-COBE, INC.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
1/28/1991
Days to Decision
84 days

HOSPAL BICART RETROFIT KIT NA/MONIT S GS HEMODIAL

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K904967
510(k) Type
Traditional
Applicant
GAMBRO-HOSP-COBE, INC.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
1/28/1991
Days to Decision
84 days