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ReTrace Ureteral Access Sheath

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K181811
510(k) Type
Special
Applicant
Coloplast A/S
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
9/7/2018
Days to Decision
63 days
Submission Type
Summary

ReTrace Ureteral Access Sheath

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K181811
510(k) Type
Special
Applicant
Coloplast A/S
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
9/7/2018
Days to Decision
63 days
Submission Type
Summary