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OTW MEGALINK SDS BILIARY STENT SYSTEM

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K000550
510(k) Type
Special
Applicant
ADVANCED CARDIOVASCULAR SYSTEMS, INC.
Country
United States
FDA Decision
Substantially Equivalent - With Limitations
Decision Date
3/17/2000
Days to Decision
28 days
Submission Type
Summary

OTW MEGALINK SDS BILIARY STENT SYSTEM

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K000550
510(k) Type
Special
Applicant
ADVANCED CARDIOVASCULAR SYSTEMS, INC.
Country
United States
FDA Decision
Substantially Equivalent - With Limitations
Decision Date
3/17/2000
Days to Decision
28 days
Submission Type
Summary