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ZEN PROGRAM (MIND 440 HEARING AID)

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K080955
510(k) Type
Traditional
Applicant
WIDEX HEARING AID CO., INC.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
6/27/2008
Days to Decision
85 days
Submission Type
Summary

ZEN PROGRAM (MIND 440 HEARING AID)

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K080955
510(k) Type
Traditional
Applicant
WIDEX HEARING AID CO., INC.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
6/27/2008
Days to Decision
85 days
Submission Type
Summary