The following data is part of a premarket notification filed by Bioject, Inc. with the FDA for Biojector 2000 Model 1b02000.
| Device ID | K960373 |
| 510k Number | K960373 |
| Device Name: | BIOJECTOR 2000 MODEL 1B02000 |
| Classification | Injector, Fluid, Non-electrically Powered |
| Applicant | BIOJECT, INC. 7620 S.W. BRIDGEPORT RD. Portland, OR 97224 |
| Contact | Mark K Norton |
| Correspondent | Mark K Norton 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 | 1996-01-26 |
| Decision Date | 1997-03-05 |
| Summary: | summary |