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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 K940116
Device Name COMPLETELY IN THE CANAL
Applicant
ARGOSY ELECTRONICS
10300 W. 70TH ST.
EDEN PRAIRIE,  MN  55344
Applicant Contact DAVID A PREVES, PH.D.
Correspondent
ARGOSY ELECTRONICS
10300 W. 70TH ST.
EDEN PRAIRIE,  MN  55344
Correspondent Contact DAVID A PREVES, PH.D.
Regulation Number874.3300
Classification Product Code
ESD  
Date Received01/10/1994
Decision Date 05/03/1994
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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