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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name colon capsule imaging system
510(k) Number K153466
Device Name PillCam COLON 2 Capsule Endoscopy System
Applicant
GIVEN IMAGING LTD.
2 Hacarmel St.
NEW INDUSTRIAL Park POB 258
Yoqneam,  IL 20962
Applicant Contact HILLA DEBBY
Correspondent
GIVEN IMAGING LTD.
2 Hacarmel St.
NEW INDUSTRIAL Park POB 258
Yoqneam,  IL 20962
Correspondent Contact HILLA DEBBY
Regulation Number876.1330
Classification Product Code
PGD  
Date Received12/01/2015
Decision Date 01/14/2016
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
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