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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 K900968
Device Name HEARING AID (ALL-IN-THE-EAR)
Applicant
Audiology of Tulsa, Inc.
4720 S. Harvard
Suite 202
Tulsa,  OK  74135
Applicant Contact LANG, PHD
Correspondent
Audiology of Tulsa, Inc.
4720 S. Harvard
Suite 202
Tulsa,  OK  74135
Correspondent Contact LANG, PHD
Regulation Number874.3300
Classification Product Code
ESD  
Date Received03/02/1990
Decision Date 04/10/1990
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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