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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 K955692
Device Name FINETONE FSC,
Applicant
FINETONE HEARING INSTRUMENTS
301 U.S. RT. 1
SCARBOROUGH,  ME  04074
Applicant Contact JEFFREY A MCLAUGHLIN
Correspondent
FINETONE HEARING INSTRUMENTS
301 U.S. RT. 1
SCARBOROUGH,  ME  04074
Correspondent Contact JEFFREY A MCLAUGHLIN
Regulation Number874.3300
Classification Product Code
ESD  
Date Received12/14/1995
Decision Date 02/02/1996
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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