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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 K872995
Device Name HEARING AID (ALL IN THE EAR)
Applicant
SOUND CRAFTERS HEARING INSTRUMENTS
6100 MARTWAY
MISSION,  KS  66202
Applicant Contact OSCAR CASSELMAN
Correspondent
SOUND CRAFTERS HEARING INSTRUMENTS
6100 MARTWAY
MISSION,  KS  66202
Correspondent Contact OSCAR CASSELMAN
Regulation Number874.3300
Classification Product Code
ESD  
Date Received07/31/1987
Decision Date 09/16/1987
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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