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SOMNOFIT

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K060795
510(k) Type
Abbreviated
Applicant
STRATEGIC COUNSEL SARL
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
12/18/2006
Days to Decision
270 days
Submission Type
Summary

SOMNOFIT

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K060795
510(k) Type
Abbreviated
Applicant
STRATEGIC COUNSEL SARL
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
12/18/2006
Days to Decision
270 days
Submission Type
Summary