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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
Applicant
INTROMEDIC CO., LTD
SUITE 1104 E&C VENTURE DREAM
TOWER 6-CHA, 197-28 GURO-DONG
GURO-GU , SEOUL,  KR 152719
Applicant Contact JIN YOUNG LEE
Correspondent
UNDERWRITERS LABORATORIES, INC.
2600 NW LAKE RD.
CAMAS,  WA  98607 -9526
Correspondent Contact MARC M MOUSER
Regulation Number874.4710
Classification Product Code
EOX  
Date Received03/08/2012
Decision Date 06/20/2012
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ear Nose & Throat
510k Review Panel Ear Nose & Throat
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
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