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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 K893887
Device Name BESTONE MODEL ITE & CANAL
Applicant
BESTONE HEARING INSTRUMENTS
426 VIRGINIA STREET,
P.O. BOX 1221
VALLEJO,  CA  94590
Applicant Contact GIL MAGILEN
Correspondent
BESTONE HEARING INSTRUMENTS
426 VIRGINIA STREET,
P.O. BOX 1221
VALLEJO,  CA  94590
Correspondent Contact GIL MAGILEN
Regulation Number874.3300
Classification Product Code
ESD  
Date Received05/30/1989
Decision Date 01/23/1990
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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