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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name esophagoscope (flexible or rigid)
510(k) Number K120702
Device Name E.G. SCAN II ESPHAGOSCOPE SYSTEM
Original Applicant
INTROMEDIC CO., LTD
suite 1104 e&c venture dream
tower 6-cha, 197-28 guro-dong
guro-gu , seoul,  KS 152719
Original Contact jin young lee
Regulation Number874.4710
Classification Product Code
EOX  
Date Received03/08/2012
Decision Date 06/20/2012
Decision substantially equivalent (SE)
Classification Advisory Committee Ear Nose & Throat
Review Advisory Committee Ear Nose & Throat
summary summary
Type Traditional
Reviewed by Third Party Yes
Expedited Review No
Combination Product No
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