HEARING AID 49 SERIES

Hearing Aid, Air Conduction

ELECTONE, INC.

The following data is part of a premarket notification filed by Electone, Inc. with the FDA for Hearing Aid 49 Series.

Pre-market Notification Details

Device IDK872554
510k NumberK872554
Device Name:HEARING AID 49 SERIES
ClassificationHearing Aid, Air Conduction
Applicant ELECTONE, INC. P.O. BOX 910 Winter Park,  FL  32790
ContactFred A Wilson
CorrespondentFred A Wilson
ELECTONE, INC. P.O. BOX 910 Winter Park,  FL  32790
Product CodeESD  
CFR Regulation Number874.3300 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1987-06-29
Decision Date1987-07-16

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