The following data is part of a premarket notification filed by Osteotech, Inc. with the FDA for Osteograf 2040 Osteograf 4060.
| Device ID | K852199 |
| 510k Number | K852199 |
| Device Name: | OSTEOGRAF 2040 OSTEOGRAF 4060 |
| Classification | Bone Grafting Material, Synthetic |
| Applicant | OSTEOTECH, INC. 1035 SHORLINE DR. San Mateo, CA 94404 |
| Contact | Lois Huang |
| Correspondent | Lois Huang OSTEOTECH, INC. 1035 SHORLINE DR. San Mateo, CA 94404 |
| Product Code | LYC |
| CFR Regulation Number | 872.3930 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-05-20 |
| Decision Date | 1985-10-07 |