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OPUS 2 - FULL CONCHA SERIES - ITE

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K974211
510(k) Type
Traditional
Applicant
BERNAFON-MAICO, INC.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
12/15/1997
Days to Decision
35 days
Submission Type
Statement

OPUS 2 - FULL CONCHA SERIES - ITE

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K974211
510(k) Type
Traditional
Applicant
BERNAFON-MAICO, INC.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
12/15/1997
Days to Decision
35 days
Submission Type
Statement