FDA 510(k) Application Details - K960567

Device Classification Name Hearing Aid, Group And Auditory Trainer

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510(K) Number K960567
Device Name Hearing Aid, Group And Auditory Trainer
Applicant MAXI-AIDS, INC.
42 EXECUTIVE BLVD.
FARMINGDALE, NY 11735 US
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Contact HARRIS BOSHAK
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Regulation Number 874.3320

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Classification Product Code EPF
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Date Received 02/09/1996
Decision Date 10/16/1996
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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