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OTOFLEX 100 TYE 1012

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K033645
510(k) Type
Traditional
Applicant
GN OTOMETRICS A/S
Country
Denmark
FDA Decision
Substantially Equivalent
Decision Date
3/31/2004
Days to Decision
132 days
Submission Type
Summary

OTOFLEX 100 TYE 1012

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K033645
510(k) Type
Traditional
Applicant
GN OTOMETRICS A/S
Country
Denmark
FDA Decision
Substantially Equivalent
Decision Date
3/31/2004
Days to Decision
132 days
Submission Type
Summary