Last synced on 22 September 2023 at 11:04 pm

OviTex PRS (Long Term Resorbable)

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K214070
510(k) Type
Traditional
Applicant
TELA Bio
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
3/21/2023
Days to Decision
449 days
Submission Type
Summary

OviTex PRS (Long Term Resorbable)

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K214070
510(k) Type
Traditional
Applicant
TELA Bio
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
3/21/2023
Days to Decision
449 days
Submission Type
Summary