FDA 510(k) Application Details - K960031

Device Classification Name Hearing Aid, Air Conduction

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510(K) Number K960031
Device Name Hearing Aid, Air Conduction
Applicant MAICO HEARING INSTRUMENTS, INC.
7375 BUSH LAKE RD.
MINNEAPOLIS, MN 55439-2029 US
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Contact SCOTT SAVRE
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Regulation Number 874.3300

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Classification Product Code ESD
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Date Received 01/02/1996
Decision Date 03/07/1996
Decision SESE - SUBST EQUIV
Classification Advisory Committee EN - Ear, Nose, & Throat
Review Advisory Committee EN - Ear, Nose, & Throat
Statement / Summary / Purged Status Statement
Type Traditional
Reviewed By Third Party N
Expedited Review



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