The following data is part of a premarket notification filed by Bioject, Inc. with the FDA for Zetajet.
| Device ID | K090003 |
| 510k Number | K090003 |
| Device Name: | ZETAJET |
| Classification | Injector, Fluid, Non-electrically Powered |
| Applicant | BIOJECT, INC. 20245 S.W. 95TH AVE. Tualatin, OR 97062 |
| Contact | Kris Richard |
| Correspondent | Kris Richard BIOJECT, INC. 20245 S.W. 95TH AVE. Tualatin, OR 97062 |
| Product Code | KZE |
| CFR Regulation Number | 880.5430 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-01-02 |
| Decision Date | 2009-04-02 |
| Summary: | summary |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() ZETAJET 77671763 not registered Dead/Abandoned |
Bioject Inc. 2009-02-17 |