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Agnes

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K192728
510(k) Type
Special
Applicant
Agnes Medical Co., Ltd
Country
South Korea
FDA Decision
Substantially Equivalent
Decision Date
10/24/2019
Days to Decision
27 days
Submission Type
Summary

Agnes

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K192728
510(k) Type
Special
Applicant
Agnes Medical Co., Ltd
Country
South Korea
FDA Decision
Substantially Equivalent
Decision Date
10/24/2019
Days to Decision
27 days
Submission Type
Summary