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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 K123821
Device Name AIO HD OTOSCOPE
Applicant
BLUE FOCUS
965 OAKLAND RD
SUITE 2B
LAWRENCEVILLE,  GA  30044
Applicant Contact KI CHEOL HAN
Correspondent
BLUE FOCUS
965 OAKLAND RD
SUITE 2B
LAWRENCEVILLE,  GA  30044
Correspondent Contact KI CHEOL HAN
Regulation Number874.4770
Classification Product Code
ERA  
Date Received12/12/2012
Decision Date 05/17/2013
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ear Nose & Throat
510k Review Panel Ear Nose & Throat
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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