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1717FCC

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K210985
510(k) Type
Special
Applicant
Rayence Co., Ltd
Country
South Korea
FDA Decision
Substantially Equivalent
Decision Date
4/28/2021
Days to Decision
27 days
Submission Type
Summary

1717FCC

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K210985
510(k) Type
Special
Applicant
Rayence Co., Ltd
Country
South Korea
FDA Decision
Substantially Equivalent
Decision Date
4/28/2021
Days to Decision
27 days
Submission Type
Summary