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FDA 510(k) Applications Submitted by RAY ENROTH
FDA 510(k) Number
Submission Date
Device Name
Applicant
K971158
03/28/1997
DUALINE 400 CIC
BERNAFON-MAICO, INC.
K973948
10/16/1997
DUALINE 100 BTE
BERNAFON-MAICO, INC.
K974069
10/28/1997
OPUS 2 - CANAL SERIES (ITC)
BERNAFON-MAICO, INC.
K974152
11/04/1997
OPUS 2 - COMPLETELY-IN-CANAL SERIES (CIC)
BERNAFON-MAICO, INC.
K974211
11/10/1997
OPUS 2 - FULL CONCHA SERIES - ITE
BERNAFON-MAICO, INC.
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