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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 K953770
Device Name REXTON MINI-PRIMO PLUS, PP142, D.C .H.I. FAMILY
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 Received08/14/1995
Decision Date 09/18/1995
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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