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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 K942702
Device Name DEEP CANAL HEARING INSTRUMENT
Applicant
Rexton, Inc.
2415 Xenium Ln.
Plymouth,  MN  55441
Applicant Contact DANIEL I ANDERSON
Correspondent
Rexton, Inc.
2415 Xenium Ln.
Plymouth,  MN  55441
Correspondent Contact DANIEL I ANDERSON
Regulation Number874.3300
Classification Product Code
ESD  
Date Received06/08/1994
Decision Date 12/21/1994
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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