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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name hearing aid, group and auditory trainer
510(k) Number K960567
Device Name HF MEGA EAR
Applicant
MAXI-AIDS, INC.
42 EXECUTIVE BLVD.
FARMINGDALE,  NY  11735
Applicant Contact HARRIS BOSHAK
Correspondent
MAXI-AIDS, INC.
42 EXECUTIVE BLVD.
FARMINGDALE,  NY  11735
Correspondent Contact HARRIS BOSHAK
Regulation Number874.3320
Classification Product Code
EPF  
Date Received02/09/1996
Decision Date 10/16/1996
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ear Nose & Throat
510k Review Panel Ear Nose & Throat
Type Traditional
Reviewed by Third Party No
Combination Product No
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