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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 K111450
Device Name MIROCAM CAPSULE ENDOSCOPE SYSTEM
Applicant
Intromedic Co., Ltd.
40 Plain St.
North Attleboro,  MA  02760
Applicant Contact JEFFREY ROBERTS
Correspondent
Intromedic Co., Ltd.
40 Plain St.
North Attleboro,  MA  02760
Correspondent Contact JEFFREY ROBERTS
Regulation Number876.1300
Classification Product Code
NEZ  
Date Received05/25/2011
Decision Date 05/18/2012
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Traditional
Clinical Trials NCT00878982
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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