The following data is part of a premarket notification filed by Biotech One, Inc. with the FDA for Bonamates Series.
| Device ID | K040650 |
| 510k Number | K040650 |
| Device Name: | BONAMATES SERIES |
| Classification | Plate, Bone |
| Applicant | BIOTECH ONE, INC. 92 COSTA BRAVA Laguna Niguel, CA 92677 |
| Contact | Karen Uyesugi |
| Correspondent | Karen Uyesugi BIOTECH ONE, INC. 92 COSTA BRAVA Laguna Niguel, CA 92677 |
| Product Code | JEY |
| CFR Regulation Number | 872.4760 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-03-11 |
| Decision Date | 2004-06-03 |