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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 K972755
Device Name V-12 LONG LIFE 675 HEARING AID
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 Received07/22/1997
Decision Date 08/05/1997
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
Predetermined Change
Control Plan Authorized		 No
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