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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 K840906
Device Name HEARING AID AUDIO-STARR A
Applicant
JADE ELECTRONICS CORP.
4221 Richmond Rd., N.W.
Walker,  MI  49534
Correspondent
JADE ELECTRONICS CORP.
4221 Richmond Rd., N.W.
Walker,  MI  49534
Regulation Number874.3300
Classification Product Code
ESD  
Date Received02/28/1984
Decision Date 05/16/1984
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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