The following data is part of a premarket notification filed by Bio-interfaces, Inc. with the FDA for Bone Graft Delivery Syringes.
| Device ID | K941431 |
| 510k Number | K941431 |
| Device Name: | BONE GRAFT DELIVERY SYRINGES |
| Classification | Syringe, Restorative And Impression Material |
| 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 | EID |
| CFR Regulation Number | 872.4565 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-03-24 |
| Decision Date | 1994-07-12 |