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WALLFLEX BILIARY RX STENT SYSTEM

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K140630
510(k) Type
Traditional
Applicant
BOSTON SCIENTIFIC
Country
United States
FDA Decision
Substantially Equivalent - With Limitations
Decision Date
5/23/2014
Days to Decision
73 days
Submission Type
Summary

WALLFLEX BILIARY RX STENT SYSTEM

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K140630
510(k) Type
Traditional
Applicant
BOSTON SCIENTIFIC
Country
United States
FDA Decision
Substantially Equivalent - With Limitations
Decision Date
5/23/2014
Days to Decision
73 days
Submission Type
Summary