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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 K971807
Device Name IN THE EAR, IN THE CANAL, COMPLETELY IN THE CANAL
Applicant
HEAR-RIGHT, INC.
2606 VILLA PROM, SUITE 74
SHEPHERD MALL
OKLAHOMA CITY,  OK  73107
Applicant Contact CRAIG BLOOMINGBURG
Correspondent
HEAR-RIGHT, INC.
2606 VILLA PROM, SUITE 74
SHEPHERD MALL
OKLAHOMA CITY,  OK  73107
Correspondent Contact CRAIG BLOOMINGBURG
Regulation Number874.3300
Classification Product Code
ESD  
Date Received05/15/1997
Decision Date 08/07/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ear Nose & Throat
510k Review Panel Ear Nose & Throat
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
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