FDA 510(k) Application Details - K961593

Device Classification Name Face Plate Hearing Aid

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510(K) Number K961593
Device Name Face Plate Hearing Aid
Applicant SEGI HEARING AID CO.
24 FIFTH AVE.
NEW YORK, NY 10011 US
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Contact LEO WEINBERGER, ESQ.
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Regulation Number 874.3300

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Classification Product Code LRB
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Date Received 04/24/1996
Decision Date 11/07/1996
Decision SESE - SUBST EQUIV
Classification Advisory Committee EN - Ear, Nose, & Throat
Review Advisory Committee EN - Ear, Nose, & Throat
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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