The following data is part of a premarket notification filed by Bio-interfaces, Inc. with the FDA for 1840 Ha Particles.
| Device ID | K921776 |
| 510k Number | K921776 |
| Device Name: | 1840 HA PARTICLES |
| Classification | Bone Grafting Material, Synthetic |
| Applicant | BIO-INTERFACES, INC. 11095 FLINTKOTE AVE. San Diego, CA 92121 |
| Contact | John Kay |
| Correspondent | John 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 | 1992-04-13 |
| Decision Date | 1992-12-04 |