FDA 510(k) Applications for Medical Device Product Code "GBO"
(Catheter, Nephrostomy, General & Plastic Surgery)

FDA 510(k) Number Applicant Device Name Decision Date
K021632 URESIL, L.P. GP GENERAL PURPOSE DRAINAGE CATHETER; MINI-PIGTAIL DRAINAGE CATHETER WITH LOCKING PIGTAIL; GP GENERAL PURPOSE DRAINAGE C 06/13/2002
K041995 URESIL, LLC MODIFICATION TO: GP GENERAL PURPOSE DRAINAGE CATHETER, MINI-PIG DRAINAGE CATHETER, NEPHROSTOMY CATHETER, BILIARY 08/19/2004


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