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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name audiometer
510(k) Number K902068
Device Name HEARING AMBASSADOR-HEAR PEN SCREENING AUDIOMETER
Applicant
STARKEY LABORATORIES, INC.
6700 WASHINGTON AVE. SOUTH
EDEN PRAIRIE,  MN  55344
Applicant Contact JERROLD LANG
Correspondent
STARKEY LABORATORIES, INC.
6700 WASHINGTON AVE. SOUTH
EDEN PRAIRIE,  MN  55344
Correspondent Contact JERROLD LANG
Regulation Number874.1050
Classification Product Code
EWO  
Date Received05/07/1990
Decision Date 08/06/1990
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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