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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 K930542
Device Name HEARING AID (ALL-IN-THE-EAR)
Applicant
ACTION LABS, INC.
P.O. BOX 2195
INDEPENDENCE,  MO  64055
Applicant Contact RON TOLES
Correspondent
ACTION LABS, INC.
P.O. BOX 2195
INDEPENDENCE,  MO  64055
Correspondent Contact RON TOLES
Regulation Number874.3300
Classification Product Code
ESD  
Date Received02/02/1993
Decision Date 04/07/1993
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
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