The following data is part of a premarket notification filed by Bioject, Inc. with the FDA for Bioject Jet Injection System.
| Device ID | K920631 |
| 510k Number | K920631 |
| Device Name: | BIOJECT JET INJECTION SYSTEM |
| Classification | Injector, Fluid, Non-electrically Powered |
| Applicant | BIOJECT, INC. 7620 S.W. BRIDGEPORT RD. Portland, OR 97224 |
| Contact | Steven F Peterson |
| Correspondent | Steven F Peterson BIOJECT, INC. 7620 S.W. BRIDGEPORT RD. Portland, OR 97224 |
| Product Code | KZE |
| CFR Regulation Number | 880.5430 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-02-12 |
| Decision Date | 1994-06-28 |