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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, air-conduction, prescription
510(k) Number K902179
Device Name VISTA - MODELS V12, V20, V23, V38, ITE HEARING AID
Applicant
VISTA LABORATORIES, INC.
P.O. BOX 1080
CENTRALIA,  WA  98531
Applicant Contact JAMES E PANNETTE
Correspondent
VISTA LABORATORIES, INC.
P.O. BOX 1080
CENTRALIA,  WA  98531
Correspondent Contact JAMES E PANNETTE
Regulation Number874.3300
Classification Product Code
ESD  
Date Received05/15/1990
Decision Date 08/10/1990
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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