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GN OTOMETRICS TYPE 1053 FREEFIT

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K110286
510(k) Type
Traditional
Applicant
GN OTOMETRICS A/S
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
4/28/2011
Days to Decision
87 days
Submission Type
Summary

GN OTOMETRICS TYPE 1053 FREEFIT

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K110286
510(k) Type
Traditional
Applicant
GN OTOMETRICS A/S
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
4/28/2011
Days to Decision
87 days
Submission Type
Summary