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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 K901341
Device Name REXTON RX12 POWER PLUS W/DUAL RECEIVER
Applicant
REXTON, INC.
2415 XENIUM LN.
PLYMOUTH,  MN  55441
Applicant Contact ANDREAS JODER
Correspondent
REXTON, INC.
2415 XENIUM LN.
PLYMOUTH,  MN  55441
Correspondent Contact ANDREAS JODER
Regulation Number874.3300
Classification Product Code
ESD  
Date Received03/22/1990
Decision Date 07/27/1990
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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