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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. SOUTH
EDEN PRAIRIE,  MN  55344
Applicant Contact AZAD J BAKSH
Correspondent
STARKEY LABORATORIES, INC.
6700 WASHINGTON AVE. SOUTH
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
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