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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Device, Assistive Listening
510(k) Number K043090
Device Name EASYLISTENER 2 FM, RADIUM FM AND VOCALIGHT INFRARED SOUND FIELD SYSTEMS
Applicant
Phonic Ear, Inc.
3880 Cypress Dr.
Petaluma,  CA  94954
Applicant Contact TODD BISSEY
Correspondent
Phonic Ear, Inc.
3880 Cypress Dr.
Petaluma,  CA  94954
Correspondent Contact TODD BISSEY
Regulation Number874.3320
Classification Product Code
LZI  
Date Received11/08/2004
Decision Date 12/23/2004
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ear Nose & Throat
510k Review Panel Ear Nose & Throat
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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