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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 K901860
Device Name INTRA III AND INTRA IV HEARING AIDS
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 Number874.3300
Classification Product Code
ESD  
Date Received04/24/1990
Decision Date 07/20/1990
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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