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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 K883773
Device Name H.A.C. MODEL-B (ALL IN THE CANAL)
Applicant
Hearing Aid Crafters
3001 Chicago Ave., #B
Riverside,  CA  92507
Applicant Contact ROLAND TURPIN
Correspondent
Hearing Aid Crafters
3001 Chicago Ave., #B
Riverside,  CA  92507
Correspondent Contact ROLAND TURPIN
Regulation Number874.3300
Classification Product Code
ESD  
Date Received09/06/1988
Decision Date 11/14/1988
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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