The following data is part of a premarket notification filed by California Medical Innovations, Inc. with the FDA for J-tip Injector System.
| Device ID | K884293 |
| 510k Number | K884293 |
| Device Name: | J-TIP INJECTOR SYSTEM |
| Classification | Injector, Fluid, Non-electrically Powered |
| Applicant | CALIFORNIA MEDICAL INNOVATIONS, INC. 24121 BIG TIMBER ST. Lake Forest, CA 92630 |
| Contact | Booher, Phd |
| Correspondent | Booher, Phd CALIFORNIA MEDICAL INNOVATIONS, INC. 24121 BIG TIMBER ST. Lake Forest, CA 92630 |
| Product Code | KZE |
| CFR Regulation Number | 880.5430 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-10-12 |
| Decision Date | 1989-01-09 |