The following data is part of a premarket notification filed by Novabone Products, Llc with the FDA for Perioglas Bone Graft Particulate.
| Device ID | K053387 |
| 510k Number | K053387 |
| Device Name: | PERIOGLAS BONE GRAFT PARTICULATE |
| Classification | Bone Grafting Material, Synthetic |
| Applicant | NovaBone Products, LLC 13709 PROGRESS BLVD., #33 Alachua, FL 32615 |
| Contact | David M Gaisser |
| Correspondent | David M Gaisser NovaBone Products, LLC 13709 PROGRESS BLVD., #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 | 2005-12-05 |
| Decision Date | 2006-02-14 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00813909010625 | K053387 | 000 |
| 00813909010618 | K053387 | 000 |