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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
Predetermined Change
Control Plan Authorized		 No
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