The following data is part of a premarket notification filed by Graftys with the FDA for Graftys Hbs.
| Device ID | K082498 |
| 510k Number | K082498 |
| Device Name: | GRAFTYS HBS |
| Classification | Filler, Bone Void, Calcium Compound |
| Applicant | GRAFTYS 415 RUE CHARLES NICOLAS LEDOUX EIFFEL PARK BAT D Aix En Provence, FR 13854 |
| Contact | Anthony Le Naour |
| Correspondent | Anthony Le Naour GRAFTYS 415 RUE CHARLES NICOLAS LEDOUX EIFFEL PARK BAT D Aix En Provence, FR 13854 |
| Product Code | MQV |
| CFR Regulation Number | 888.3045 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-08-29 |
| Decision Date | 2009-02-25 |
| Summary: | summary |