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FDA 510(k) Application Details - K123864
Device Classification Name
System, Imaging, Gastrointestinal, Wireless, Capsule
More FDA Info for this Device
510(K) Number
K123864
Device Name
System, Imaging, Gastrointestinal, Wireless, Capsule
Applicant
GIVEN IMAGING LTD.
SHAAR YOKNEAM (HERMON BUILDING
NEW INDUSTRIAL ZONE,
YOKNEAM (P.O.BOX 258) 20692 IL
Other 510(k) Applications for this Company
Contact
Tim Thomas
Other 510(k) Applications for this Contact
Regulation Number
876.1300
More FDA Info for this Regulation Number
Classification Product Code
NEZ
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
12/17/2012
Decision Date
08/12/2013
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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