The following data is part of a premarket notification filed by Pavel Jordan & Associates, Inc. with the FDA for Instaject Ii.
| Device ID | K883164 |
| 510k Number | K883164 |
| Device Name: | INSTAJECT II |
| Classification | Introducer, Syringe Needle |
| Applicant | PAVEL JORDAN & ASSOCIATES, INC. 3001 CHAPEL HILL RD. Orange, CA 92667 |
| Contact | Krawitz |
| Correspondent | 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 | 1988-07-27 |
| Decision Date | 1988-10-04 |