Last synced on 2 December 2022 at 11:04 pm

3Shape Splint Design

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K191911
510(k) Type
Traditional
Applicant
3Shape A/S
Country
Denmark
FDA Decision
Substantially Equivalent
Decision Date
11/27/2019
Days to Decision
133 days
Submission Type
Summary

3Shape Splint Design

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K191911
510(k) Type
Traditional
Applicant
3Shape A/S
Country
Denmark
FDA Decision
Substantially Equivalent
Decision Date
11/27/2019
Days to Decision
133 days
Submission Type
Summary