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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
Predetermined Change
Control Plan Authorized		 No
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