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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 K964898
Device Name IN THE EAR HEARING AID
Applicant
Keytone Hearing Laboratory
11701 I-30, Suite 100
Little Rock,  AR  72209
Applicant Contact KRISTI KEY
Correspondent
Keytone Hearing Laboratory
11701 I-30, Suite 100
Little Rock,  AR  72209
Correspondent Contact KRISTI KEY
Regulation Number874.3300
Classification Product Code
ESD  
Date Received12/06/1996
Decision Date 04/21/1997
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
Predetermined Change
Control Plan Authorized		 No
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