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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 K943687
Device Name FEDELITY F495, VIENNATONE ALPP II
Applicant
STARKEY LABORATORIES, INC.
6700 WASHINGTON AVE. SO.
EDEN PRAIRIE,  MN  55344
Applicant Contact RICK STROMBERG
Correspondent
STARKEY LABORATORIES, INC.
6700 WASHINGTON AVE. SO.
EDEN PRAIRIE,  MN  55344
Correspondent Contact RICK STROMBERG
Regulation Number874.3300
Classification Product Code
ESD  
Date Received07/29/1994
Decision Date 10/20/1994
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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