The following data is part of a premarket notification filed by Biomimetic Pharmaceuticals Inc. with the FDA for Osteomimetic Synthetic Bone Matrix.
| Device ID | K051775 |
| 510k Number | K051775 |
| Device Name: | OSTEOMIMETIC SYNTHETIC BONE MATRIX |
| Classification | Filler, Bone Void, Calcium Compound |
| Applicant | BIOMIMETIC PHARMACEUTICALS INC. 389 A NICHOL MILL LANE Franklin, TN 37067 |
| Contact | Sandra Williamson |
| Correspondent | Sandra Williamson BIOMIMETIC PHARMACEUTICALS INC. 389 A NICHOL MILL LANE Franklin, TN 37067 |
| Product Code | MQV |
| CFR Regulation Number | 888.3045 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-07-01 |
| Decision Date | 2005-09-06 |
| Summary: | summary |