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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 K904756
Device Name MATRICS
Applicant
KERR CORPORATION (DANBURY)
28200 WICK RD P.O. BOX 455
ROMULUS,  MI  48174
Applicant Contact BENJAMIN WEAVER
Correspondent
KERR CORPORATION (DANBURY)
28200 WICK RD P.O. BOX 455
ROMULUS,  MI  48174
Correspondent Contact BENJAMIN WEAVER
Regulation Number874.3300
Classification Product Code
ESD  
Date Received10/19/1990
Decision Date 03/15/1991
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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