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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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