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Xtreme-Loop

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K191053
510(k) Type
Traditional
Applicant
Xiros Ltd
Country
United Kingdom
FDA Decision
Substantially Equivalent
Decision Date
7/17/2019
Days to Decision
89 days
Submission Type
Summary

Xtreme-Loop

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K191053
510(k) Type
Traditional
Applicant
Xiros Ltd
Country
United Kingdom
FDA Decision
Substantially Equivalent
Decision Date
7/17/2019
Days to Decision
89 days
Submission Type
Summary