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OTOMAG BONE CONDUCTION HEARING SYSTEM

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K100193
510(k) Type
Traditional
Applicant
SOPHONO, INC
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
5/18/2010
Days to Decision
116 days
Submission Type
Summary

OTOMAG BONE CONDUCTION HEARING SYSTEM

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K100193
510(k) Type
Traditional
Applicant
SOPHONO, INC
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
5/18/2010
Days to Decision
116 days
Submission Type
Summary