The following data is part of a premarket notification filed by Bioject Medical Technologies Inc. with the FDA for Bioject Needle-free Injection Management System.
| Device ID | K121270 |
| 510k Number | K121270 |
| Device Name: | BIOJECT NEEDLE-FREE INJECTION MANAGEMENT SYSTEM |
| Classification | Injector, Fluid, Non-electrically Powered |
| Applicant | BIOJECT MEDICAL TECHNOLOGIES INC. 7180 SW Sandburg St Ste 100 Tigard, OR 97223 |
| Contact | Christine Breitbach |
| Correspondent | Christine Breitbach BIOJECT MEDICAL TECHNOLOGIES INC. 7180 SW Sandburg St Ste 100 Tigard, OR 97223 |
| Product Code | KZE |
| CFR Regulation Number | 880.5430 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-04-26 |
| Decision Date | 2012-07-19 |
| Summary: | summary |