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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, Bone Conduction
510(k) Number K935701
Device Name VIENNATONE AN, VIENNATONE AS FIDELITY F228, FIDELITY F229
Applicant
STARKEY LABORATORIES, INC.
6700 WASHINGTON AVE. SOUTH
EDEN PRAIRIE,  MN  55344
Applicant Contact RICK STROMBERG
Correspondent
STARKEY LABORATORIES, INC.
6700 WASHINGTON AVE. SOUTH
EDEN PRAIRIE,  MN  55344
Correspondent Contact RICK STROMBERG
Regulation Number874.3302
Classification Product Code
LXB  
Date Received11/30/1993
Decision Date 05/10/1994
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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