Last synced on 27 January 2023 at 11:04 pm

Clear Aligner

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K203688
510(k) Type
Traditional
Applicant
Wuxi EA Medical Instruments Technologies Limited.
Country
China
FDA Decision
Substantially Equivalent
Decision Date
10/8/2021
Days to Decision
295 days
Submission Type
Summary

Clear Aligner

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K203688
510(k) Type
Traditional
Applicant
Wuxi EA Medical Instruments Technologies Limited.
Country
China
FDA Decision
Substantially Equivalent
Decision Date
10/8/2021
Days to Decision
295 days
Submission Type
Summary