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SOMNODENT FUSION, CLASSIC; SOMNODENT FUSION, FLEX

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K140278
510(k) Type
Traditional
Applicant
SOMNOMED INC.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
6/20/2014
Days to Decision
137 days
Submission Type
Summary

SOMNODENT FUSION, CLASSIC; SOMNODENT FUSION, FLEX

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K140278
510(k) Type
Traditional
Applicant
SOMNOMED INC.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
6/20/2014
Days to Decision
137 days
Submission Type
Summary