FDA 510(k) Application Details - K904731

Device Classification Name Hearing Aid, Air Conduction

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510(K) Number K904731
Device Name Hearing Aid, Air Conduction
Applicant QUALITONE
4931 WEST 35TH ST.
MINNEAPOLIS, MN US
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Contact A BROWN
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Regulation Number 874.3300

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Classification Product Code ESD
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Date Received 10/17/1990
Decision Date 12/17/1990
Decision SE - Substantially Equivalent
Classification Advisory Committee EN - Ear, Nose, & Throat
Review Advisory Committee EN - Ear, Nose, & Throat
Statement / Summary / Purged Status
Type Traditional
Reviewed By Third Party N
Expedited Review



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