Microline Surgical, Inc. · Class II · Cleared Apr 23, 2024
| K-number | K234147 |
| Device name | ReNew XR Handpiece, 25cm, with Reference Markings (3943M); ReNew XR Handpiece, 34cm, with Reference Markings (3941M); ReNew XR Handpiece, 42cm, with Reference Markings (3942M); ReNew XR Handpiece, Ratcheted, 25cm, with Reference Markings (3946M); ReNew XR Handpiece, Ratcheted, 34cm, with Reference Markings (3944M); ReNew XR Handpiece, Ratcheted, 42cm, with Reference Markings (3945M) |
| Applicant | Microline Surgical, Inc. |
| Product code | GEI |
| Device class | Class II |
| Decision date | Apr 23, 2024 |
| Decision | Substantially Equivalent |
| Regulation | — |
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