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DIAETCH Economic Package Type A, DIATECH Regular Package, DIAETCH Refill Package Type A, DIAETCH Intro Kit

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K192273
510(k) Type
Traditional
Applicant
Diadent Group International
Country
South Korea
FDA Decision
Substantially Equivalent
Decision Date
2/7/2020
Days to Decision
169 days
Submission Type
Summary

DIAETCH Economic Package Type A, DIATECH Regular Package, DIAETCH Refill Package Type A, DIAETCH Intro Kit

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K192273
510(k) Type
Traditional
Applicant
Diadent Group International
Country
South Korea
FDA Decision
Substantially Equivalent
Decision Date
2/7/2020
Days to Decision
169 days
Submission Type
Summary