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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 K932189
Device Name IN-THE-EAR HEARING AID
Applicant
Lifestyle Hearing, Inc.
5470 E. Speedway #A104
Tucson,  AR  85712
Applicant Contact WAYNE BRAASTAD
Correspondent
Lifestyle Hearing, Inc.
5470 E. Speedway #A104
Tucson,  AR  85712
Correspondent Contact WAYNE BRAASTAD
Regulation Number874.3300
Classification Product Code
ESD  
Date Received05/06/1993
Decision Date 06/14/1993
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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