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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 K915537
Device Name EARBEAR OTOSCOPE
Applicant
EARBEAR CO.
4279 BRIGADOON DR.
SHOREVIEW,  MN  56126
Applicant Contact PAUL A BURGIO
Correspondent
EARBEAR CO.
4279 BRIGADOON DR.
SHOREVIEW,  MN  56126
Correspondent Contact PAUL A BURGIO
Regulation Number874.4770
Classification Product Code
ERA  
Date Received12/10/1991
Decision Date 01/24/1992
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
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