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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Face Plate Hearing Aid
510(k) Number K873031
Device Name STARKEY MODEL P1 MODULE
Applicant
Starkey Laboratories, Inc.
6700 Washington Ave. S
Eden Prairie,  MN  55344
Applicant Contact AZAD J BAKSH
Correspondent
Starkey Laboratories, Inc.
6700 Washington Ave. S
Eden Prairie,  MN  55344
Correspondent Contact AZAD J BAKSH
Regulation Number874.3300
Classification Product Code
LRB  
Date Received08/04/1987
Decision Date 02/08/1988
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
Predetermined Change
Control Plan Authorized		 No
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