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Zilver 635 Biliary Stent

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K163018
510(k) Type
Traditional
Applicant
Cook Ireland Ltd.
Country
Ireland
FDA Decision
Substantially Equivalent - With Limitations
Decision Date
12/23/2016
Days to Decision
53 days
Submission Type
Summary

Zilver 635 Biliary Stent

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K163018
510(k) Type
Traditional
Applicant
Cook Ireland Ltd.
Country
Ireland
FDA Decision
Substantially Equivalent - With Limitations
Decision Date
12/23/2016
Days to Decision
53 days
Submission Type
Summary