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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name calibrator, hearing aid / earphone and analysis systems
510(k) Number K896301
Device Name MODEL 340 PROBE MIC SYSTEM
Applicant
VIRTUAL CORP.
P.O. BOX 8885
PORTLAND,  OR  97207
Applicant Contact JONATHAN D BIRCK
Correspondent
VIRTUAL CORP.
P.O. BOX 8885
PORTLAND,  OR  97207
Correspondent Contact JONATHAN D BIRCK
Regulation Number874.3310
Classification Product Code
ETW  
Date Received10/30/1989
Decision Date 01/16/1990
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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