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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 K862050
Device Name LIFESOUND CUSTOM ITE
Applicant
Lifesounds, Inc.
300 Long Beach Blvd. #403
Long Beach,  CA  90802
Applicant Contact ROBERT E HUGHES
Correspondent
Lifesounds, Inc.
300 Long Beach Blvd. #403
Long Beach,  CA  90802
Correspondent Contact ROBERT E HUGHES
Regulation Number874.3300
Classification Product Code
ESD  
Date Received05/29/1986
Decision Date 06/23/1986
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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