FDA 510(k) K233991, CanGaroo RM Antibacterial Envelope, by Elutia, Inc.
FDA 510(k) K233991, CanGaroo RM Antibacterial Envelope, by Elutia, Inc.
| 510(k) Number | K233991 |
| Device Classification Name | Mesh, Surgical |
| Device Name | CanGaroo RM Antibacterial Envelope |
| Applicant | Elutia, Inc. 1100 Old Ellis Rd. Suite 1200 Roswell, GA 30076 |
| Regulation Number | 878.33 |
| Classification Product Code | FTM |
| Date Received | 12/18/2023 |
| Decision Date | 06/14/2024 |
| Decision | Substantially Equivalent (SESE) |
| Regulation Medical Specialty | General & Plastic Surgery |
| 510k Review Panel | General & Plastic Surgery |
| Type | Traditional |
| Reviewed by Third Party | No |
| Combination Product | Yes |
| Total Pages | 4840 |
| Redacted Pages | 4557 |
| Unredacted Pages | 283 |
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