FDA 510(k) Application Details - K963881

Device Classification Name Hearing Aid, Air Conduction

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510(K) Number K963881
Device Name Hearing Aid, Air Conduction
Applicant AUTHORIZED HEARING SYSTEMS, INC.
806 BEAVER ST.
BRISTOL, PA 19007 US
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Contact HENRY SMITH
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Regulation Number 874.3300

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Classification Product Code ESD
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Date Received 09/26/1996
Decision Date 11/26/1996
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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