The following data is part of a premarket notification filed by Purgo Biologics Inc. with the FDA for The Graft Bone Substitute.
| Device ID | K191737 |
| 510k Number | K191737 |
| Device Name: | The Graft Bone Substitute |
| Classification | Bone Grafting Material, Animal Source |
| Applicant | Purgo Biologics Inc. E-607, 700, Pangyo-ro Bundang-gu Seongnam-si, KR 13516 |
| Contact | Eun Ho Kim |
| Correspondent | Eun Ho Kim Purgo Biologics Inc. E-607, 700, Pangyo-ro Bundang-gu Seongnam-si, KR 13516 |
| Product Code | NPM |
| CFR Regulation Number | 872.3930 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-06-28 |
| Decision Date | 2020-02-14 |