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 |