HEARING AID (ALL-IN-THE-EAR)

Hearing Aid, Air Conduction

MARKETING SPECIALIST, INC.

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

Pre-market Notification Details

Device IDK872212
510k NumberK872212
Device Name:HEARING AID (ALL-IN-THE-EAR)
ClassificationHearing Aid, Air Conduction
Applicant MARKETING SPECIALIST, INC. 101 NORTH MAIN ST. Du Bois,  PA  15801
ContactRicky A Pape
CorrespondentRicky A Pape
MARKETING SPECIALIST, INC. 101 NORTH MAIN ST. Du Bois,  PA  15801
Product CodeESD  
CFR Regulation Number874.3300 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1987-06-09
Decision Date1987-07-10

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