The following data is part of a premarket notification filed by Bio-lok Intl., Inc. with the FDA for Bonegen - Tr.
| Device ID | K060285 |
| 510k Number | K060285 |
| Device Name: | BONEGEN - TR |
| Classification | Bone Grafting Material, Synthetic |
| Applicant | BIO-LOK INTL., INC. 505 MORRIS AVENUE, SUITE 104 Springfield, NJ 07081 |
| Contact | Harold Alexander |
| Correspondent | Harold Alexander BIO-LOK INTL., INC. 505 MORRIS AVENUE, SUITE 104 Springfield, NJ 07081 |
| Product Code | LYC |
| CFR Regulation Number | 872.3930 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-02-03 |
| Decision Date | 2006-03-16 |
| Summary: | summary |