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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
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