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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 K880333
Device Name CUSTOM I.T.E. HEARING AIDS CE-5, CE-6, CE-7
Applicant
Starkey Laboratories, Inc.
6700 Washington Ave. S.
Eden Prairie,  MN  55344
Applicant Contact KEITH GUGGENBERGER
Correspondent
Starkey Laboratories, Inc.
6700 Washington Ave. S.
Eden Prairie,  MN  55344
Correspondent Contact KEITH GUGGENBERGER
Regulation Number874.3300
Classification Product Code
ESD  
Date Received01/26/1988
Decision Date 03/18/1988
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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