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VORTEK HYDRO-COATED DOUBLE LOOP URETERAL STENTS

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K170362
510(k) Type
Traditional
Applicant
Coloplast Corp
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
11/15/2017
Days to Decision
282 days
Submission Type
Summary

VORTEK HYDRO-COATED DOUBLE LOOP URETERAL STENTS

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K170362
510(k) Type
Traditional
Applicant
Coloplast Corp
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
11/15/2017
Days to Decision
282 days
Submission Type
Summary