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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, Master
510(k) Number K802812
Device Name RIONET HEARING AID
Applicant
KINDEL & ANDERSON
4221 Richmond Rd., N.W.
Walker,  MI  49534
Correspondent
KINDEL & ANDERSON
4221 Richmond Rd., N.W.
Walker,  MI  49534
Regulation Number874.3330
Classification Product Code
KHL  
Date Received11/07/1980
Decision Date 11/26/1980
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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