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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 K180732
Device Name MiroCam Capsule Endoscope System
Applicant
Intromedic Co., Ltd.
Suite 1105, 1106 E&C Venture Dream Tower 6-Cha,
Guro-Dong, Guro-Gu
Seoul,  KR 08375
Applicant Contact Jinyoung Lee
Correspondent
Intromedic Co., Ltd.
Suite 1105, 1106 E&C Venture Dream Tower 6-Cha,
Guro-Dong, Guro-Gu
Seoul,  KR 08375
Correspondent Contact Jinyoung Lee
Regulation Number876.1300
Classification Product Code
NEZ  
Date Received03/20/2018
Decision Date 11/08/2018
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
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