The following data is part of a premarket notification filed by Mizzy, Inc. with the FDA for Mizzy Syrijet Mark Iv.
| Device ID | K790193 |
| 510k Number | K790193 |
| Device Name: | MIZZY SYRIJET MARK IV |
| Classification | Injector, Jet, Mechanical-powered |
| Applicant | MIZZY, INC. 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | EGM |
| CFR Regulation Number | 872.4475 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1979-01-26 |
| Decision Date | 1979-04-23 |