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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, Air-Conduction, Prescription
510(k) Number K962228
Device Name MODEL ALPHA BEHIND-THE-EAR HEARING INSTRUMENT
Applicant
Ototech Intl., Inc.
3400 NW 56th
Oklahoma City,  OK  73112
Applicant Contact DAVID A HOUGH
Correspondent
Ototech Intl., Inc.
3400 NW 56th
Oklahoma City,  OK  73112
Correspondent Contact DAVID A HOUGH
Regulation Number874.3300
Classification Product Code
ESD  
Date Received06/10/1996
Decision Date 08/28/1996
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ear Nose & Throat
510k Review Panel Ear Nose & Throat
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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