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Perfadex Plus

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K170826
510(k) Type
Traditional
Applicant
XVIVO Perfusion AB
Country
Sweden
FDA Decision
Substantially Equivalent
Decision Date
6/22/2018
Days to Decision
459 days
Submission Type
Summary

Perfadex Plus

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K170826
510(k) Type
Traditional
Applicant
XVIVO Perfusion AB
Country
Sweden
FDA Decision
Substantially Equivalent
Decision Date
6/22/2018
Days to Decision
459 days
Submission Type
Summary