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HANAROSTENT FASTTM Biliary (NNN)

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K183396
510(k) Type
Traditional
Applicant
M.I.Tech Co., Ltd.
Country
South Korea
FDA Decision
Substantially Equivalent - With Limitations
Decision Date
2/11/2019
Days to Decision
66 days
Submission Type
Summary

HANAROSTENT FASTTM Biliary (NNN)

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K183396
510(k) Type
Traditional
Applicant
M.I.Tech Co., Ltd.
Country
South Korea
FDA Decision
Substantially Equivalent - With Limitations
Decision Date
2/11/2019
Days to Decision
66 days
Submission Type
Summary