The following data is part of a premarket notification filed by Unicare Biomedical with the FDA for Unigrafe.
| Device ID | K982699 |
| 510k Number | K982699 |
| Device Name: | UNIGRAFE |
| Classification | Bone Grafting Material, Synthetic |
| Applicant | UNICARE BIOMEDICAL 25951 LA CUESTA AVE. Laguna Hills, CA 92653 |
| Contact | Stan Yang |
| Correspondent | Stan Yang UNICARE BIOMEDICAL 25951 LA CUESTA AVE. Laguna Hills, CA 92653 |
| Product Code | LYC |
| CFR Regulation Number | 872.3930 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-08-03 |
| Decision Date | 1998-10-20 |
| Summary: | summary |