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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, Esophageal, Wireless, Capsule
510(k) Number K180171
Device Name PillCam Patency System
Applicant
Given Imaging Ltd.
2 Hacarmet St. New Industrial Park
POB 258
Yoqneam,  IL 20692
Applicant Contact Hilla Debby
Correspondent
Given Imaging Ltd.
2 Hacarmet St. New Industrial Park
POB 258
Yoqneam,  IL 20692
Correspondent Contact Hilla Debby
Regulation Number876.1300
Classification Product Code
NSI  
Subsequent Product Codes
NEZ   PGD  
Date Received01/22/2018
Decision Date 03/08/2018
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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