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FDA 510(k) Application Details - K063118
Device Classification Name
Tubes, Gastrointestinal (And Accessories)
More FDA Info for this Device
510(K) Number
K063118
Device Name
Tubes, Gastrointestinal (And Accessories)
Applicant
C.R. BARD, INC.
5425 WEST AMELIA EARHART DR.
SALT LAKE CITY, UT 84116 US
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Contact
SUSAN SCOTT
Other 510(k) Applications for this Contact
Regulation Number
876.5980
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Classification Product Code
KNT
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
10/11/2006
Decision Date
02/13/2007
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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