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Somnowell Mandibular Advancement Appliance (MAA)

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K150941
510(k) Type
Traditional
Applicant
Somnowell Ltd.
Country
United Kingdom
FDA Decision
Substantially Equivalent
Decision Date
5/22/2015
Days to Decision
44 days
Submission Type
Summary

Somnowell Mandibular Advancement Appliance (MAA)

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K150941
510(k) Type
Traditional
Applicant
Somnowell Ltd.
Country
United Kingdom
FDA Decision
Substantially Equivalent
Decision Date
5/22/2015
Days to Decision
44 days
Submission Type
Summary