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Ensmile

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K222619
510(k) Type
Traditional
Applicant
Ensmile Pvt Ltd
Country
Pakistan
FDA Decision
Substantially Equivalent
Decision Date
3/16/2023
Days to Decision
198 days
Submission Type
Summary

Ensmile

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K222619
510(k) Type
Traditional
Applicant
Ensmile Pvt Ltd
Country
Pakistan
FDA Decision
Substantially Equivalent
Decision Date
3/16/2023
Days to Decision
198 days
Submission Type
Summary