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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Hearing Aid, Air-Conduction, Prescription
510(k) Number K872212
Device Name HEARING AID (ALL-IN-THE-EAR)
Applicant
MARKETING SPECIALIST, INC.
101 NORTH MAIN ST.
DU BOIS,  PA  15801
Applicant Contact RICKY A PAPE
Correspondent
MARKETING SPECIALIST, INC.
101 NORTH MAIN ST.
DU BOIS,  PA  15801
Correspondent Contact RICKY A PAPE
Regulation Number874.3300
Classification Product Code
ESD  
Date Received06/09/1987
Decision Date 07/10/1987
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ear Nose & Throat
510k Review Panel Ear Nose & Throat
Type Traditional
Reviewed by Third Party No
Combination Product No
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