Last synced on 26 May 2023 at 11:04 pm

GAMBRO FH 22H FIBER HEMOFLTR/PRISMA FH 22H BLOOD TUBING/HEMOFLTR SET

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K955497
510(k) Type
Traditional
Applicant
COBE RENAL CARE, INC.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
9/25/1997
Days to Decision
664 days
Submission Type
Statement

GAMBRO FH 22H FIBER HEMOFLTR/PRISMA FH 22H BLOOD TUBING/HEMOFLTR SET

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K955497
510(k) Type
Traditional
Applicant
COBE RENAL CARE, INC.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
9/25/1997
Days to Decision
664 days
Submission Type
Statement