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MARS MONITOR ITC US, MARS TREATMENT KIT TYPE 1116/1 - X-MARS US, PRISMAFLEX CONTROL UNIT

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K133807
510(k) Type
Traditional
Applicant
GAMBRO RENAL PRODUCTS, INC.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
3/26/2014
Days to Decision
100 days
Submission Type
Statement

MARS MONITOR ITC US, MARS TREATMENT KIT TYPE 1116/1 - X-MARS US, PRISMAFLEX CONTROL UNIT

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K133807
510(k) Type
Traditional
Applicant
GAMBRO RENAL PRODUCTS, INC.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
3/26/2014
Days to Decision
100 days
Submission Type
Statement