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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 K131131
FOIA Releasable 510(k) K131131
Device Name E.G. SCAN(TM) II ESOPHAGOSCOPE SYSTEM
Applicant
INTROMEDIC CO., LTD
3550 WILSHIRE BLVD #738
LOS ANGELES,  CA  90010 -2401
Applicant Contact STEVE KWON
Correspondent
INTROMEDIC CO., LTD
3550 WILSHIRE BLVD #738
LOS ANGELES,  CA  90010 -2401
Correspondent Contact STEVE KWON
Regulation Number874.4710
Classification Product Code
EOX  
Date Received04/22/2013
Decision Date 06/21/2013
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ear Nose & Throat
510k Review Panel Ear Nose & Throat
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
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