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Serena Sleep Night Guard

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K230495
510(k) Type
Traditional
Applicant
Meris Investment Group
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
10/13/2023
Days to Decision
232 days
Submission Type
Summary

Serena Sleep Night Guard

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K230495
510(k) Type
Traditional
Applicant
Meris Investment Group
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
10/13/2023
Days to Decision
232 days
Submission Type
Summary