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3Shape Ortho System

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K152086
510(k) Type
Traditional
Applicant
3Shape A/S
Country
Denmark
FDA Decision
Substantially Equivalent
Decision Date
4/28/2016
Days to Decision
276 days
Submission Type
Summary

3Shape Ortho System

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K152086
510(k) Type
Traditional
Applicant
3Shape A/S
Country
Denmark
FDA Decision
Substantially Equivalent
Decision Date
4/28/2016
Days to Decision
276 days
Submission Type
Summary