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Planmed Clarity 2D and Clarity S

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K192317
510(k) Type
Traditional
Applicant
Planmed Oy
Country
Finland
FDA Decision
Substantially Equivalent
Decision Date
10/23/2020
Days to Decision
424 days
Submission Type
Summary

Planmed Clarity 2D and Clarity S

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K192317
510(k) Type
Traditional
Applicant
Planmed Oy
Country
Finland
FDA Decision
Substantially Equivalent
Decision Date
10/23/2020
Days to Decision
424 days
Submission Type
Summary