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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 K971296
Device Name TONDI, MODELS U-03, U-2M1, U-2M4, KA-01, KA-02, KA-03, KA-03A, KA-04, KA-04A, KA-05
Applicant
National Hearing Aid Dist., Inc.
301 U.S. Rt. 1
Scarborough,  ME  04074
Applicant Contact PAUL MENEZES
Correspondent
National Hearing Aid Dist., Inc.
301 U.S. Rt. 1
Scarborough,  ME  04074
Correspondent Contact PAUL MENEZES
Regulation Number874.3300
Classification Product Code
ESD  
Date Received04/07/1997
Decision Date 06/20/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ear Nose & Throat
510k Review Panel Ear Nose & Throat
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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