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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 K121326
Device Name LANTOS 3D EAR SCANNER
Applicant
LANTOS TECHNOLOGIES
20310 sw 48th st
southwest ranches,  FL  33332
Contact john greenbaum
Regulation Number874.4770
Classification Product Code
ERA  
Subsequent Product Code
ESD  
Date Received05/02/2012
Decision Date 01/25/2013
Decision substantially equivalent (SE)
Classification Advisory Committee Ear Nose & Throat
Review Advisory Committee Ear Nose & Throat
summary summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
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