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EVOLUTION BILIARY STENT SYSTEM

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K121430
510(k) Type
Traditional
Applicant
COOK IRELAND LTD
Country
Ireland
FDA Decision
Substantially Equivalent - With Limitations
Decision Date
3/1/2013
Days to Decision
291 days
Submission Type
Summary

EVOLUTION BILIARY STENT SYSTEM

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K121430
510(k) Type
Traditional
Applicant
COOK IRELAND LTD
Country
Ireland
FDA Decision
Substantially Equivalent - With Limitations
Decision Date
3/1/2013
Days to Decision
291 days
Submission Type
Summary