Allwin Medical Devices, Inc. · Class II · Cleared May 5, 2023
| K-number | K220781 |
| Device name | ARMADA Ureteral Dilator Set, ARMADA Nottingham One Step Dilator, ARMADA Amplatz Renal Dilator Sets, ARMADA Renal Dilator, Glider Amplatz Sheath, ARMADA Renal Dilator with Amplatz Sheath, Fascial Dilator Set, Introducer Sheath, Introducer Catheter |
| Applicant | Allwin Medical Devices, Inc. |
| Product code | EZN |
| Device class | Class II |
| Decision date | May 5, 2023 |
| Decision | Substantially Equivalent |
| Regulation | 876.5470 |
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