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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 K970939
Device Name VISTA V-38 CIC
Applicant
VISTA LABS
409 S. TOWER
CENTRALIA,  WA  98531
Applicant Contact JAMES E PANNETTE
Correspondent
VISTA LABS
409 S. TOWER
CENTRALIA,  WA  98531
Correspondent Contact JAMES E PANNETTE
Regulation Number874.3300
Classification Product Code
ESD  
Date Received03/13/1997
Decision Date 06/06/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ear Nose & Throat
510k Review Panel Ear Nose & Throat
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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