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PONTO BONE ANCHORED HEARING SYSTEM

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K121228
510(k) Type
Traditional
Applicant
OTICON MEDICAL AB
Country
Sweden
FDA Decision
Substantially Equivalent
Decision Date
9/7/2012
Days to Decision
137 days
Submission Type
Summary

PONTO BONE ANCHORED HEARING SYSTEM

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K121228
510(k) Type
Traditional
Applicant
OTICON MEDICAL AB
Country
Sweden
FDA Decision
Substantially Equivalent
Decision Date
9/7/2012
Days to Decision
137 days
Submission Type
Summary