OVERSIGHT PROGRAM FOR IN-OFFICE ASSEMBLY, HRNG AID

Face Plate Hearing Aid

AUDINA HEARING INSTRUMENT

The following data is part of a premarket notification filed by Audina Hearing Instrument with the FDA for Oversight Program For In-office Assembly, Hrng Aid.

Pre-market Notification Details

Device IDK897023
510k NumberK897023
Device Name:OVERSIGHT PROGRAM FOR IN-OFFICE ASSEMBLY, HRNG AID
ClassificationFace Plate Hearing Aid
Applicant AUDINA HEARING INSTRUMENT 150 WILDMERE ST. Longwood,  FL  32750
ContactFrank J Robilotta
CorrespondentFrank J Robilotta
AUDINA HEARING INSTRUMENT 150 WILDMERE ST. Longwood,  FL  32750
Product CodeLRB  
CFR Regulation Number874.3300 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1989-12-19
Decision Date1990-03-16

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