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EVS 4343A, EVS 4343AG, EVS 3643A, EVS 3643AG

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K192400
510(k) Type
Special
Applicant
DRTECH Corporation
Country
South Korea
FDA Decision
Substantially Equivalent
Decision Date
10/3/2019
Days to Decision
30 days
Submission Type
Summary

EVS 4343A, EVS 4343AG, EVS 3643A, EVS 3643AG

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K192400
510(k) Type
Special
Applicant
DRTECH Corporation
Country
South Korea
FDA Decision
Substantially Equivalent
Decision Date
10/3/2019
Days to Decision
30 days
Submission Type
Summary