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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Otoscope
510(k) Number K922752
Device Name STARKEY LABORATORIES OTOSCOPE
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 Number874.4770
Classification Product Code
ERA  
Date Received06/08/1992
Decision Date 09/04/1992
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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