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IH Implant System

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K153521
510(k) Type
Traditional
Applicant
Sewon Medix Inc.
Country
South Korea
FDA Decision
Substantially Equivalent
Decision Date
10/14/2016
Days to Decision
311 days
Submission Type
Summary

IH Implant System

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K153521
510(k) Type
Traditional
Applicant
Sewon Medix Inc.
Country
South Korea
FDA Decision
Substantially Equivalent
Decision Date
10/14/2016
Days to Decision
311 days
Submission Type
Summary