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Dextile Anatomical Mesh

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K192443
510(k) Type
Traditional
Applicant
Sofradim Production
Country
France
FDA Decision
Substantially Equivalent
Decision Date
12/6/2019
Days to Decision
91 days
Submission Type
Summary

Dextile Anatomical Mesh

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K192443
510(k) Type
Traditional
Applicant
Sofradim Production
Country
France
FDA Decision
Substantially Equivalent
Decision Date
12/6/2019
Days to Decision
91 days
Submission Type
Summary