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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 K862545
Device Name HEARING AID (ALL-IN-EAR)
Applicant
Vibrasonic, Inc.
1135 Strand
Missoula,  MT  59801
Applicant Contact WILLIAM V FOWLER
Correspondent
Vibrasonic, Inc.
1135 Strand
Missoula,  MT  59801
Correspondent Contact WILLIAM V FOWLER
Regulation Number874.3300
Classification Product Code
ESD  
Date Received07/03/1986
Decision Date 07/16/1986
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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