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ARCHSTENT BILIARY SYSTEM

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K113582
510(k) Type
Traditional
Applicant
OSTIAL CORPORATION
Country
United States
FDA Decision
Substantially Equivalent - With Limitations
Decision Date
6/29/2012
Days to Decision
207 days
Submission Type
Summary

ARCHSTENT BILIARY SYSTEM

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K113582
510(k) Type
Traditional
Applicant
OSTIAL CORPORATION
Country
United States
FDA Decision
Substantially Equivalent - With Limitations
Decision Date
6/29/2012
Days to Decision
207 days
Submission Type
Summary