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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 K974242
Device Name ARGOSY PROGRAMMABLE ONQUE
Applicant
Argosy Electronics
10300 W. 70th St.
P.O. Box 59072
Eden Prairie,  MN  55344
Applicant Contact RONALD A SCICLUNA
Correspondent
Argosy Electronics
10300 W. 70th St.
P.O. Box 59072
Eden Prairie,  MN  55344
Correspondent Contact RONALD A SCICLUNA
Regulation Number874.3300
Classification Product Code
ESD  
Date Received11/12/1997
Decision Date 01/20/1998
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ear Nose & Throat
510k Review Panel Ear Nose & Throat
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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