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X-Suit NIR Biliary Metallic Stent

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K150487
510(k) Type
Traditional
Applicant
MEDINOL LTD.
Country
Israel
FDA Decision
Substantially Equivalent - With Limitations
Decision Date
2/12/2016
Days to Decision
352 days
Submission Type
Statement

X-Suit NIR Biliary Metallic Stent

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K150487
510(k) Type
Traditional
Applicant
MEDINOL LTD.
Country
Israel
FDA Decision
Substantially Equivalent - With Limitations
Decision Date
2/12/2016
Days to Decision
352 days
Submission Type
Statement