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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 K933097
Device Name SOUND SELECTOR FULL-SERVICE AUDIOMETER
Applicant
Ensoniq Corp.
155 Greay Valley Pkwy.
Malvern,  PA  19355
Applicant Contact ED GAUTHIER
Correspondent
Ensoniq Corp.
155 Greay Valley Pkwy.
Malvern,  PA  19355
Correspondent Contact ED GAUTHIER
Regulation Number874.1050
Classification Product Code
EWO  
Date Received06/24/1993
Decision Date 01/24/1994
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
Predetermined Change
Control Plan Authorized		 No
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