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T1-CS, T1-C

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K183475
510(k) Type
Traditional
Applicant
Osstem Implant Co., Ltd.
Country
South Korea
FDA Decision
Substantially Equivalent
Decision Date
8/30/2019
Days to Decision
256 days
Submission Type
Summary

T1-CS, T1-C

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K183475
510(k) Type
Traditional
Applicant
Osstem Implant Co., Ltd.
Country
South Korea
FDA Decision
Substantially Equivalent
Decision Date
8/30/2019
Days to Decision
256 days
Submission Type
Summary