FINETONE FSC,

Hearing Aid, Air Conduction

FINETONE HEARING INSTRUMENTS

The following data is part of a premarket notification filed by Finetone Hearing Instruments with the FDA for Finetone Fsc,.

Pre-market Notification Details

Device IDK955692
510k NumberK955692
Device Name:FINETONE FSC,
ClassificationHearing Aid, Air Conduction
Applicant FINETONE HEARING INSTRUMENTS 301 U.S. RT. 1 Scarborough,  ME  04074
ContactJeffrey A Mclaughlin
CorrespondentJeffrey A Mclaughlin
FINETONE HEARING INSTRUMENTS 301 U.S. RT. 1 Scarborough,  ME  04074
Product CodeESD  
CFR Regulation Number874.3300 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1995-12-14
Decision Date1996-02-02

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