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EXALIS, SOFTWARE VERSION 1.15

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K083158
510(k) Type
Traditional
Applicant
GAMBRO, INC.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
6/5/2009
Days to Decision
224 days
Submission Type
Summary

EXALIS, SOFTWARE VERSION 1.15

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K083158
510(k) Type
Traditional
Applicant
GAMBRO, INC.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
6/5/2009
Days to Decision
224 days
Submission Type
Summary