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Ponto Bone Anchored Hearing System, MONO Surgery Kit

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K203807
510(k) Type
Special
Applicant
Oticon Medical AB
Country
Sweden
FDA Decision
Substantially Equivalent
Decision Date
3/3/2021
Days to Decision
65 days
Submission Type
Summary

Ponto Bone Anchored Hearing System, MONO Surgery Kit

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K203807
510(k) Type
Special
Applicant
Oticon Medical AB
Country
Sweden
FDA Decision
Substantially Equivalent
Decision Date
3/3/2021
Days to Decision
65 days
Submission Type
Summary