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FDA 510(k) Application Details - K162989
Device Classification Name
Catheter, Retention Type, Balloon
More FDA Info for this Device
510(K) Number
K162989
Device Name
Catheter, Retention Type, Balloon
Applicant
TELEFLEX MEDICAL, INC.
3015 CARRINGTON MILLS BLVD
MORRISVILLE, NC 27560 US
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Contact
LORI PFOHL
Other 510(k) Applications for this Contact
Regulation Number
876.5130
More FDA Info for this Regulation Number
Classification Product Code
EZL
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
10/27/2016
Decision Date
02/24/2017
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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