The following data is part of a premarket notification filed by Graftys with the FDA for Graftys Bcp.
| Device ID | K073064 |
| 510k Number | K073064 |
| Device Name: | GRAFTYS BCP |
| 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 | 2007-10-30 |
| Decision Date | 2008-03-11 |
| Summary: | summary |