FDA 510(k) Application Details - K955288

Device Classification Name Hearing Aid, Air Conduction

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510(K) Number K955288
Device Name Hearing Aid, Air Conduction
Applicant CROWN DELTA CORP.
1550 FRONT ST.
YORKTOWN HEIGHTS, NY 10598 US
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Contact LAURENCE COLIN
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Regulation Number 874.3300

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Classification Product Code ESD
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Date Received 11/16/1995
Decision Date 02/02/1996
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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