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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 K861532
Device Name RX-33S INTRA MINI CANAL MODULE
Applicant
Rexton, Inc.
768 Foster Ave.
Bensenville,  IL  60106
Applicant Contact THOMAS O YATES
Correspondent
Rexton, Inc.
768 Foster Ave.
Bensenville,  IL  60106
Correspondent Contact THOMAS O YATES
Regulation Number874.3300
Classification Product Code
ESD  
Date Received04/24/1986
Decision Date 06/05/1986
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
Predetermined Change
Control Plan Authorized		 No
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