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IH Implant System

Page Type
Cleared 510(K)
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)
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