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OSSTEM Implant System - Abutment

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K161689
510(k) Type
Traditional
Applicant
OSSTEM IMPLANT Co., Ltd.
Country
South Korea
FDA Decision
Substantially Equivalent
Decision Date
5/22/2017
Days to Decision
336 days
Submission Type
Summary

OSSTEM Implant System - Abutment

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K161689
510(k) Type
Traditional
Applicant
OSSTEM IMPLANT Co., Ltd.
Country
South Korea
FDA Decision
Substantially Equivalent
Decision Date
5/22/2017
Days to Decision
336 days
Submission Type
Summary