The following data is part of a premarket notification filed by Purgo Biologics Inc. with the FDA for The Graft Natural Bone Substitute.
| Device ID | K173188 |
| 510k Number | K173188 |
| Device Name: | The Graft Natural Bone Substitute |
| Classification | Bone Grafting Material, Animal Source |
| Applicant | Purgo Biologics Inc. E-607, 700, Pangyo-ro Bundang-gu Seongnam-si, KR 13516 |
| Contact | Hana Jung |
| Correspondent | Hana Jung 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 | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-10-02 |
| Decision Date | 2018-07-20 |
| Summary: | summary |