The following data is part of a premarket notification filed by Vitajet Corp. with the FDA for Vitajet.
Device ID | K962625 |
510k Number | K962625 |
Device Name: | VITAJET |
Classification | Injector, Fluid, Non-electrically Powered |
Applicant | VITAJET CORP. 27075 CABOT RD. SUITE 102 Laguna Hills, CA 92653 |
Contact | Sergio Landau |
Correspondent | Sergio Landau VITAJET CORP. 27075 CABOT RD. SUITE 102 Laguna Hills, CA 92653 |
Product Code | KZE |
CFR Regulation Number | 880.5430 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1996-07-05 |
Decision Date | 1996-12-10 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
VITAJET 74366838 1838619 Live/Registered |
BIOJECT, INC. 1993-03-11 |
VITAJET 73516681 1350517 Dead/Cancelled |
VITAJET INDUSTRIA E COMERCIO LTDA. 1985-01-08 |