FDA 510(k) Applications Submitted by BERNAFON-MAICO, INC.

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.
K971080 03/25/1997 MAICO MA52 BERNAFON-MAICO, INC.
K981142 03/30/1998 MAICO MA53 BERNAFON-MAICO, INC.
K962275 06/13/1996 MAICO MA25 SERIES II WITH SPEECH BERNAFON-MAICO, INC.
K982723 08/05/1998 MAICO MA42 BERNAFON-MAICO, INC.


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