HI-TECH LAB MODEL CONCHA ALL IN EAR

Hearing Aid, Air Conduction

HI-TECH LABORATORIES, INC.

The following data is part of a premarket notification filed by Hi-tech Laboratories, Inc. with the FDA for Hi-tech Lab Model Concha All In Ear.

Pre-market Notification Details

Device IDK853967
510k NumberK853967
Device Name:HI-TECH LAB MODEL CONCHA ALL IN EAR
ClassificationHearing Aid, Air Conduction
Applicant HI-TECH LABORATORIES, INC. P.O. BOX 1330 1008 A STREET Blue Springs,  MO  64015
ContactHoward E Sander
CorrespondentHoward E Sander
HI-TECH LABORATORIES, INC. P.O. BOX 1330 1008 A STREET Blue Springs,  MO  64015
Product CodeESD  
CFR Regulation Number874.3300 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1985-09-26
Decision Date1985-12-27

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