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Pitch PaSoft Tissue Reinforcement Device

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K230671
510(k) Type
Traditional
Applicant
Xiros Ltd
Country
United Kingdom
FDA Decision
Substantially Equivalent
Decision Date
5/31/2023
Days to Decision
82 days
Submission Type
Summary

Pitch PaSoft Tissue Reinforcement Device

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K230671
510(k) Type
Traditional
Applicant
Xiros Ltd
Country
United Kingdom
FDA Decision
Substantially Equivalent
Decision Date
5/31/2023
Days to Decision
82 days
Submission Type
Summary