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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, Group And Auditory Trainer
510(k) Number K974658
Device Name INFRARED GROUP AMPLIFICATION SYSTEM, INFRARED EMITTER, INFRARED BODY WORN RECEIVER, INFRARED HEADSET RECEIVER-STEREO, IT
Applicant
PHONIC EAR, INC.
3880 CYPRESS DR.
PETALUMA,  CA  94954 -7600
Applicant Contact ROBERT L REINKE
Correspondent
PHONIC EAR, INC.
3880 CYPRESS DR.
PETALUMA,  CA  94954 -7600
Correspondent Contact ROBERT L REINKE
Regulation Number874.3320
Classification Product Code
EPF  
Date Received12/15/1997
Decision Date 02/25/1998
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
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