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FLEXSTENT BILIARY SELF-EXPANDING STENT SYSTEM

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K112522
510(k) Type
Traditional
Applicant
FLEXIBLE STENTING SOLUTIONS, INC.
Country
United States
FDA Decision
Substantially Equivalent - With Limitations
Decision Date
12/30/2011
Days to Decision
121 days
Submission Type
Statement

FLEXSTENT BILIARY SELF-EXPANDING STENT SYSTEM

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K112522
510(k) Type
Traditional
Applicant
FLEXIBLE STENTING SOLUTIONS, INC.
Country
United States
FDA Decision
Substantially Equivalent - With Limitations
Decision Date
12/30/2011
Days to Decision
121 days
Submission Type
Statement