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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 K960494
Device Name EUROLINE A312 SERIES OF BEHIND THE EAR AIR CONDUCTION HEARING AIDS
Applicant
STARKEY LABORATORIES, INC.
6600 WASHINGTON AVE. SOUTH
EDEN PRAIRIE,  MN  55344
Applicant Contact RICK STROMBERG
Correspondent
STARKEY LABORATORIES, INC.
6600 WASHINGTON AVE. SOUTH
EDEN PRAIRIE,  MN  55344
Correspondent Contact RICK STROMBERG
Regulation Number874.3300
Classification Product Code
ESD  
Date Received01/30/1996
Decision Date 03/01/1996
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ear Nose & Throat
510k Review Panel Ear Nose & Throat
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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