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PRISMA HF 1000 SET, PRISMA HF 1000 PRE-SET

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K011221
510(k) Type
Traditional
Applicant
GAMBRO RENAL PRODUCTS
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
10/31/2001
Days to Decision
194 days
Submission Type
Statement

PRISMA HF 1000 SET, PRISMA HF 1000 PRE-SET

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K011221
510(k) Type
Traditional
Applicant
GAMBRO RENAL PRODUCTS
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
10/31/2001
Days to Decision
194 days
Submission Type
Statement