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Ponto Bone Anchored Hearing system/ Abutment, 14mm. Ponto Bone Anchored Hearing System / Wide implant, 4mm, with abutment, 14 mm

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K142678
510(k) Type
Traditional
Applicant
OTICON MEDICAL AB
Country
Sweden
FDA Decision
Substantially Equivalent
Decision Date
1/21/2015
Days to Decision
124 days
Submission Type
Summary

Ponto Bone Anchored Hearing system/ Abutment, 14mm. Ponto Bone Anchored Hearing System / Wide implant, 4mm, with abutment, 14 mm

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K142678
510(k) Type
Traditional
Applicant
OTICON MEDICAL AB
Country
Sweden
FDA Decision
Substantially Equivalent
Decision Date
1/21/2015
Days to Decision
124 days
Submission Type
Summary