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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 K950730
Device Name GROUP AUDITORY TRAINER (GROUP AMPLIFICATION SYSTEM)
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 Received02/16/1995
Decision Date 06/30/1995
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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