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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Imaging, Gastrointestinal, Wireless, Capsule
510(k) Number K123428
Device Name MIROCAM CAPSULE ENDOSCOPE SYSTEM
Applicant
INTROMEDIC CO., LTD
STE 1104, E&C VENTURE DREAM TOWER 6-CHA
197-28 GURO-DONG
GURO-GU , SEOUL,  KR 152-719
Applicant Contact STEVE KWON
Correspondent
INTROMEDIC CO., LTD
STE 1104, E&C VENTURE DREAM TOWER 6-CHA
197-28 GURO-DONG
GURO-GU , SEOUL,  KR 152-719
Correspondent Contact STEVE KWON
Regulation Number876.1300
Classification Product Code
NEZ  
Date Received11/07/2012
Decision Date 05/20/2013
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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