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FDA 510(k) Application Details - K102543
Device Classification Name
Electrode, Ph, Stomach
More FDA Info for this Device
510(K) Number
K102543
Device Name
Electrode, Ph, Stomach
Applicant
GIVEN IMAGING LTD.
P.O. BOX 258
NEW INDUSTRIAL PARK
YOQNEAM 20692 IL
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Contact
Tim Thomas
Other 510(k) Applications for this Contact
Regulation Number
876.1400
More FDA Info for this Regulation Number
Classification Product Code
FFT
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
09/03/2010
Decision Date
12/01/2010
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
GU - Gastroenterology & Urology
Review Advisory Committee
GU - Gastroenterology & Urology
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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