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Optixon 1-Day

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K201013
510(k) Type
Traditional
Applicant
Optixon Inc.
Country
South Korea
FDA Decision
Substantially Equivalent
Decision Date
9/18/2020
Days to Decision
154 days
Submission Type
Summary

Optixon 1-Day

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K201013
510(k) Type
Traditional
Applicant
Optixon Inc.
Country
South Korea
FDA Decision
Substantially Equivalent
Decision Date
9/18/2020
Days to Decision
154 days
Submission Type
Summary