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FDA 510(k) Application Details - K112137
Device Classification Name
Catheter, Straight
More FDA Info for this Device
510(K) Number
K112137
Device Name
Catheter, Straight
Applicant
C.R. BARD, INC.
8195 INDUSTRIAL BLVD.
COVINGTON, GA 30014 US
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Contact
STACCI CRONK
Other 510(k) Applications for this Contact
Regulation Number
876.5130
More FDA Info for this Regulation Number
Classification Product Code
EZD
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More FDA Info for this Product Code
Date Received
07/26/2011
Decision Date
08/26/2011
Decision
SESK - SUBST EQUIV - KIT
Classification Advisory Committee
GU - Gastroenterology & Urology
Review Advisory Committee
GU - Gastroenterology & Urology
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
Y
Expedited Review
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