Cook Ireland, Ltd. · Class II · Cleared Feb 27, 2018
| K-number | K172044 |
| Device name | Cotton-Huibregtse Stent, Cotton-Leung Biliary Stent, Cotton-Leung Sof-Flex Biliary Stent, Soehendra Tannenbaum Biliary Stent, Zimmon Biliary Stent, Guiding Catheter, Pushing catheter, Fusion pushing catheter, Stent Introducer Set, Fusion Oasis One Action Sent Introduction System, Zimmon Biliary Stent Set, Oasis One Action Stent Introduction System, Solus Double Pigtail Stent and Introduction System, Cotton-Huibregtse Biliary Stent Set, Cotton-Leung Biliary Stent Set, Oasis One Action S |
| Applicant | Cook Ireland, Ltd. |
| Product code | FGE |
| Device class | Class II |
| Decision date | Feb 27, 2018 |
| Decision | Substantially Equivalent |
| Regulation | 876.5010 |
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