The following data is part of a premarket notification filed by Blue Sky Bio with the FDA for Synthetic Glass Bone Graft Material.
| Device ID | K000633 |
| 510k Number | K000633 |
| Device Name: | SYNTHETIC GLASS BONE GRAFT MATERIAL |
| Classification | Bone Grafting Material, Synthetic |
| Applicant | BLUE SKY BIO 3722 AVE. SAUSALITO Irvine, CA 92606 |
| Contact | Rita Giebel |
| Correspondent | Rita Giebel BLUE SKY BIO 3722 AVE. SAUSALITO Irvine, CA 92606 |
| Product Code | LYC |
| CFR Regulation Number | 872.3930 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-02-25 |
| Decision Date | 2000-05-25 |