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NIR BILLIARY STENT SYSTEM; MARSHAL BALLOON DILATATION CATHETER

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K002133
510(k) Type
Traditional
Applicant
BOSTON SCIENTIFIC CORP.
Country
United States
FDA Decision
Substantially Equivalent - With Limitations
Decision Date
10/12/2000
Days to Decision
90 days
Submission Type
Summary

NIR BILLIARY STENT SYSTEM; MARSHAL BALLOON DILATATION CATHETER

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K002133
510(k) Type
Traditional
Applicant
BOSTON SCIENTIFIC CORP.
Country
United States
FDA Decision
Substantially Equivalent - With Limitations
Decision Date
10/12/2000
Days to Decision
90 days
Submission Type
Summary