The following data is part of a premarket notification filed by Bio-interfaces, Inc. with the FDA for Bio-apatite 6140 Ha Particles.
| Device ID | K950567 |
| 510k Number | K950567 |
| Device Name: | BIO-APATITE 6140 HA PARTICLES |
| Classification | Bone Grafting Material, Synthetic |
| Applicant | BIO-INTERFACES, INC. 11095 FLINTKOTE AVE. San Diego, CA 92121 |
| Contact | John F Kay |
| Correspondent | John F Kay BIO-INTERFACES, INC. 11095 FLINTKOTE AVE. San Diego, CA 92121 |
| Product Code | LYC |
| CFR Regulation Number | 872.3930 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-02-08 |
| Decision Date | 1995-05-09 |