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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Electrode, Ph, Stomach
510(k) Number K102543
Device Name BRAVO PH MONITORING SYSTEM AND ACCESSORIES
Applicant
GIVEN IMAGING LTD.
P.O. BOX 258
NEW INDUSTRIAL PARK
YOQNEAM,  IL 20692
Applicant Contact Tim Thomas
Correspondent
GIVEN IMAGING LTD.
P.O. BOX 258
NEW INDUSTRIAL PARK
YOQNEAM,  IL 20692
Correspondent Contact Tim Thomas
Regulation Number876.1400
Classification Product Code
FFT  
Date Received09/03/2010
Decision Date 12/01/2010
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
Recalls CDRH Recalls
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