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 |