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PERFADEX AND PERFADEX WITH THAM

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K091989
510(k) Type
Special
Applicant
XVIVO PERFUSION AB
Country
Sweden
FDA Decision
Substantially Equivalent
Decision Date
10/1/2010
Days to Decision
456 days
Submission Type
Summary

PERFADEX AND PERFADEX WITH THAM

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K091989
510(k) Type
Special
Applicant
XVIVO PERFUSION AB
Country
Sweden
FDA Decision
Substantially Equivalent
Decision Date
10/1/2010
Days to Decision
456 days
Submission Type
Summary