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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 K911689
Device Name MODEL 330 SCREENING AUDIOMETER
Applicant
Virtual Corp.
521 SW 11th
Suite 400
Portland,  OR  97205
Applicant Contact JONATHAN D BIRCK
Correspondent
Virtual Corp.
521 SW 11th
Suite 400
Portland,  OR  97205
Correspondent Contact JONATHAN D BIRCK
Regulation Number874.1050
Classification Product Code
EWO  
Date Received04/16/1991
Decision Date 10/21/1991
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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