The following data is part of a premarket notification filed by Novabone Products, Llc with the FDA for Novabone-bbg-resorbable Bone Graft Substitute.
| Device ID | K033994 |
| 510k Number | K033994 |
| Device Name: | NOVABONE-BBG-RESORBABLE BONE GRAFT SUBSTITUTE |
| Classification | Bone Grafting Material, Synthetic |
| Applicant | NovaBone Products, LLC ONE PROGRESS BLVD. SUITE 33 Alachua, FL 32615 |
| Contact | David M Gaisser |
| Correspondent | David M Gaisser NovaBone Products, LLC ONE PROGRESS BLVD. SUITE 33 Alachua, FL 32615 |
| Product Code | LYC |
| CFR Regulation Number | 872.3930 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-12-24 |
| Decision Date | 2004-03-25 |
| Summary: | summary |