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PreXion3D Explorer

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K190320
510(k) Type
Traditional
Applicant
PreXion Corporation
Country
Japan
FDA Decision
Substantially Equivalent
Decision Date
4/15/2019
Days to Decision
61 days
Submission Type
Summary

PreXion3D Explorer

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K190320
510(k) Type
Traditional
Applicant
PreXion Corporation
Country
Japan
FDA Decision
Substantially Equivalent
Decision Date
4/15/2019
Days to Decision
61 days
Submission Type
Summary