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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Audiometer
510(k) Number K943215
Device Name DISPOSABLE AUDIOMETER EARPHONE CUSHION COVER
Applicant
KENNETH ULLRICH
4369 ANNA LN.
WENATCHEE,  WA  98801
Applicant Contact KENNETH ULLRICH
Correspondent
KENNETH ULLRICH
4369 ANNA LN.
WENATCHEE,  WA  98801
Correspondent Contact KENNETH ULLRICH
Regulation Number874.1050
Classification Product Code
EWO  
Date Received07/05/1994
Decision Date 05/12/1995
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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