The following data is part of a premarket notification filed by U.s. Biomaterials Corp. with the FDA for Novabone-bioglass Bone Graft Particulate.
| Device ID | K000149 |
| 510k Number | K000149 |
| Device Name: | NOVABONE-BIOGLASS BONE GRAFT PARTICULATE |
| Classification | Bone Grafting Material, Synthetic |
| Applicant | U.S. BIOMATERIALS CORP. ONE PROGRESS BLVD. Alachua, FL 32615 |
| Contact | Albert Fosmoe |
| Correspondent | Albert Fosmoe U.S. BIOMATERIALS CORP. ONE PROGRESS BLVD. Alachua, FL 32615 |
| Product Code | LYC |
| CFR Regulation Number | 872.3930 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-01-19 |
| Decision Date | 2000-02-07 |