The following data is part of a premarket notification filed by Bioject, Inc. with the FDA for Biojector Syringe System.
| Device ID | K861687 |
| 510k Number | K861687 |
| Device Name: | BIOJECTOR SYRINGE SYSTEM |
| Classification | Injector, Fluid, Non-electrically Powered |
| Applicant | BIOJECT, INC. 630 PARKSIDE CENTER, 2020 SW FOUTH AVE Portland, OR 97201 |
| Contact | Alfred Aronson |
| Correspondent | Alfred Aronson BIOJECT, INC. 630 PARKSIDE CENTER, 2020 SW FOUTH AVE Portland, OR 97201 |
| Product Code | KZE |
| CFR Regulation Number | 880.5430 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-05-02 |
| Decision Date | 1987-04-23 |