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Smartcord, Smartcord X

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K171577
510(k) Type
Traditional
Applicant
EASTDENT Co., Ltd
Country
South Korea
FDA Decision
Substantially Equivalent
Decision Date
5/3/2018
Days to Decision
338 days
Submission Type
Summary

Smartcord, Smartcord X

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K171577
510(k) Type
Traditional
Applicant
EASTDENT Co., Ltd
Country
South Korea
FDA Decision
Substantially Equivalent
Decision Date
5/3/2018
Days to Decision
338 days
Submission Type
Summary