The following data is part of a premarket notification filed by Gradtech with the FDA for Gradtech Syringe System.
| Device ID | K864732 |
| 510k Number | K864732 |
| Device Name: | GRADTECH SYRINGE SYSTEM |
| Classification | Injector, Jet, Mechanical-powered |
| Applicant | GRADTECH 5150 S. JULIAN DR. SUITE 204 Tucson, AZ 85706 |
| Contact | Byron Economidy |
| Correspondent | Byron Economidy GRADTECH 5150 S. JULIAN DR. SUITE 204 Tucson, AZ 85706 |
| Product Code | EGM |
| CFR Regulation Number | 872.4475 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-12-04 |
| Decision Date | 1987-04-15 |