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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 K952450
Device Name WIDE DYNAMIC RANGE COMPRESSION WITH ACTIVE TONE CONTROL
Applicant
ARGOSY ELECTRONICS
10300 WEST 70TH ST.
P.O. BOX 59072
EDEN PRAIRIE,  MN  55344
Applicant Contact DAVID A PREVES
Correspondent
ARGOSY ELECTRONICS
10300 WEST 70TH ST.
P.O. BOX 59072
EDEN PRAIRIE,  MN  55344
Correspondent Contact DAVID A PREVES
Regulation Number874.3300
Classification Product Code
ESD  
Date Received05/25/1995
Decision Date 07/06/1995
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
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