FDA 510(k) Applications Submitted by Samuel Engelman

FDA 510(k) Number Submission Date Device Name Applicant
K180182 01/23/2018 Dual Lumen Ureteral Access Catheter, Flexi-Tip Dual Lumen Ureteral Access Catheter Cook Incorporated
K171600 06/01/2017 Renal Access Cobra Catheter, Kumpe Access Catheter Cook Incorporated
K172278 07/28/2017 Firlit-Kluge Urethral Stent, Koyle Diaper Stent, Zaontz Urethral Stent Cook Incorporated
K173105 09/29/2017 Endoscopic Cap, Check-Flo Adapter, Side-arm Adapter, Tuohy-Borst Adapter Cook Incorporated
K182781 10/01/2018 PTS Professional Chemistry Kit Polymer Technology Systems, Inc. d/b/a PTS Diagnostics
K173657 11/29/2017 Radiance(TM) Clear Sharklet(R) Silicone Foley Catheter Cook Incorporated


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