The following data is part of a premarket notification filed by Pavel Jordan & Associates, Inc. with the FDA for Instaject.
Device ID | K870474 |
510k Number | K870474 |
Device Name: | INSTAJECT |
Classification | Introducer, Syringe Needle |
Applicant | PAVEL JORDAN & ASSOCIATES, INC. 3001 CHAPEL HILL RD. Orange, CA 92667 |
Contact | Willie Krawitz |
Correspondent | Willie Krawitz PAVEL JORDAN & ASSOCIATES, INC. 3001 CHAPEL HILL RD. Orange, CA 92667 |
Product Code | KZH |
CFR Regulation Number | 880.6920 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1987-02-03 |
Decision Date | 1987-03-13 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
INSTAJECT 73592756 1415710 Dead/Cancelled |
PAVEL JORDAN & ASSOCIATES 1986-04-11 |