HEARING AID (ALL-IN-THE-EAR)

Hearing Aid, Air Conduction

AUDINA HEARING INSTRUMENT

The following data is part of a premarket notification filed by Audina Hearing Instrument with the FDA for Hearing Aid (all-in-the-ear).

Pre-market Notification Details

Device IDK953960
510k NumberK953960
Device Name:HEARING AID (ALL-IN-THE-EAR)
ClassificationHearing Aid, Air Conduction
Applicant AUDINA HEARING INSTRUMENT 150 EAST WILDMERE ST. Longwood,  FL  32750
ContactFrank J Robilotta
CorrespondentFrank J Robilotta
AUDINA HEARING INSTRUMENT 150 EAST WILDMERE ST. Longwood,  FL  32750
Product CodeESD  
CFR Regulation Number874.3300 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1995-08-22
Decision Date1995-09-12

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