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Zilver 518 Biliary Stent, 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
K182980
510(k) Type
Special
Applicant
Cook Ireland Ltd
Country
Ireland
FDA Decision
Substantially Equivalent - With Limitations
Decision Date
11/16/2018
Days to Decision
18 days
Submission Type
Summary

Zilver 518 Biliary Stent, 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
K182980
510(k) Type
Special
Applicant
Cook Ireland Ltd
Country
Ireland
FDA Decision
Substantially Equivalent - With Limitations
Decision Date
11/16/2018
Days to Decision
18 days
Submission Type
Summary