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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. S
Eden Prairie,  MN  55344
Applicant Contact JERROLD LANG
Correspondent
Starkey Laboratories, Inc.
6700 Washington Ave. S
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
Predetermined Change
Control Plan Authorized		 No
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