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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 K915683
Device Name REXTON RX12 WITH HORIZON PROGRAMMABLE OPTION
Applicant
REXTON, INC.
2415 XENIUM LN.
PLYMOUTH,  MN  55441
Applicant Contact CHRIS CONGER
Correspondent
REXTON, INC.
2415 XENIUM LN.
PLYMOUTH,  MN  55441
Correspondent Contact CHRIS CONGER
Regulation Number874.3300
Classification Product Code
ESD  
Date Received12/19/1991
Decision Date 01/09/1992
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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