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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 K950451
Device Name M-29 PP-PC, M-29 PP-O/PC
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 Received02/03/1995
Decision Date 03/21/1995
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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