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Serena Sleep Block Mandibular Advancement (BMA), Serena Sleep Elastic Mandibular Advancement (EMA)

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K203606
510(k) Type
Traditional
Applicant
Meris Investment Group
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
3/10/2021
Days to Decision
90 days
Submission Type
Summary

Serena Sleep Block Mandibular Advancement (BMA), Serena Sleep Elastic Mandibular Advancement (EMA)

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K203606
510(k) Type
Traditional
Applicant
Meris Investment Group
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
3/10/2021
Days to Decision
90 days
Submission Type
Summary