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R STENT BILIARY ENDOPROSTHESIS

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K010107
510(k) Type
Traditional
Applicant
ORBUS MEDICAL TECHNOLOGIES
Country
United States
FDA Decision
Substantially Equivalent - With Limitations
Decision Date
7/31/2001
Days to Decision
200 days
Submission Type
Summary

R STENT BILIARY ENDOPROSTHESIS

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K010107
510(k) Type
Traditional
Applicant
ORBUS MEDICAL TECHNOLOGIES
Country
United States
FDA Decision
Substantially Equivalent - With Limitations
Decision Date
7/31/2001
Days to Decision
200 days
Submission Type
Summary