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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 K880969
Device Name STAR 22,33,66 SERIES & STARKEY H. AND SM SERIES
Applicant
STARKEY LABORATORIES, INC.
6700 WASHINGTON AVE. SOUTH
EDEN PRAIRIE,  MN  55344
Applicant Contact KEITH GUGGENBERGER
Correspondent
STARKEY LABORATORIES, INC.
6700 WASHINGTON AVE. SOUTH
EDEN PRAIRIE,  MN  55344
Correspondent Contact KEITH GUGGENBERGER
Regulation Number874.3300
Classification Product Code
ESD  
Date Received03/08/1988
Decision Date 04/11/1988
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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