Definition: Cber Review Required - Previously Regulated As A Device Under 21 Cfr 882.5975, Now Regulated In Cber Under Section 361 As Banked Human Tissue. See Definition At §1271.3(d). Subject To Donor Eligibility, Good Tissue Practice, Registration And Listing
| Device Type ID | 3737 |
| Device Name | Human Lyophilized Dura Mater |
| Regulation Description | Human Dura Mater. |
| Regulation Medical Specialty | Neurology |
| Review Panel | Neurology |
| Premarket Review | Office Of Device Evaluation (ODE) Division Of Neurological And Physical Medicine Devices (DNPMD) Neurodiagnostic And Neurosurgical Devices Branch (NDNB) |
| Submission Type | 510(k) |
| CFR Regulation Number | 882.5975 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | LEM |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | Yes |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 3737 |
| Device | Human Lyophilized Dura Mater |
| Product Code | LEM |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Human Dura Mater. |
| CFR Regulation Number | 882.5975 [🔎] |