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1417WCE, 1417WCE-HR, 1417WCE-HS, 1417WCE-GF

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K231467
510(k) Type
Special
Applicant
Rayence Co., Ltd
Country
South Korea
FDA Decision
Substantially Equivalent
Decision Date
6/21/2023
Days to Decision
30 days
Submission Type
Summary

1417WCE, 1417WCE-HR, 1417WCE-HS, 1417WCE-GF

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K231467
510(k) Type
Special
Applicant
Rayence Co., Ltd
Country
South Korea
FDA Decision
Substantially Equivalent
Decision Date
6/21/2023
Days to Decision
30 days
Submission Type
Summary