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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 K952454
Device Name EXPANDER WITH ACTIVE TONE CONTROL
Applicant
Argosy Electronics
10300 W. 70th St.
Eden Prairie,  MN  55344
Applicant Contact DAVID A PREVES
Correspondent
Argosy Electronics
10300 W. 70th St.
Eden Prairie,  MN  55344
Correspondent Contact DAVID A PREVES
Regulation Number874.3300
Classification Product Code
ESD  
Date Received05/25/1995
Decision Date 06/21/1995
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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