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MADSEN ACCUSCREEN TYPE 1077

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K132957
510(k) Type
Traditional
Applicant
GN OTOMETRICS
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
2/27/2014
Days to Decision
160 days
Submission Type
Summary

MADSEN ACCUSCREEN TYPE 1077

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K132957
510(k) Type
Traditional
Applicant
GN OTOMETRICS
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
2/27/2014
Days to Decision
160 days
Submission Type
Summary