Mizzy Syrijet Mark IV
FDA 510(k) K790193 · Mizzy, Inc.
510(k) numberK790193
Submission
- Device name
- Mizzy Syrijet Mark IV
- Applicant
- Mizzy, Inc.
Walker, MI, US - Received
- January 26, 1979
- Decision date
- April 23, 1979
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Other 510(k)s with product code EGM
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K243427 | QuickSleeper 5EGM · Traditional | Dentalhitec | 08/01/2025SE |
| K083811 | W&H Handpiece Anesto, Model: RA-5EGM · Traditional | W&H Dentalwerk Buermoos GmbH | 01/14/2010SE |
| K964802 | Cyberjet Local Anesthesia SystemEGM · Traditional | Intra Vantage, Inc. | 05/27/1997SE |
| K962017 | Hypodermic Jet Injection ApparatusEGM · Traditional | American Jet Injector Corp. | 07/26/1996SE |
| K904279 | Paroject Anesthetic SyringeEGM · Traditional | Ronvig Instruments, Ltd. | 12/07/1990SE |
| K864294 | Henke-Ject Pressure Syringe (Modification)EGM · Traditional | Smith & Nephew, Inc. | 11/04/1987SE |
| K864732 | Gradtech Syringe SystemEGM · Traditional | Gradtech | 04/15/1987SE |
| K864861 | Instrumentations Unlimited Syringe SystemEGM · Traditional | Instrumentations Unltd. | 02/13/1987SE |
| K834361 | JSB Jet SyringeEGM · Traditional | C.B.S. Biotechnics, Inc. | 03/05/1984SE |
| K821273 | Mayo Scissor Straight 6 3/4EGM · Traditional | Conphar, Inc. | 05/28/1982SE |
Questions and answers
When was Mizzy Syrijet Mark IV cleared by the FDA?
Mizzy Syrijet Mark IV (K790193) received a 510(k) decision of Substantially Equivalent on April 23, 1979, 87 days after the submission was received.
What is the product code of K790193?
The FDA product code is EGM – Injector, Jet, Mechanical-Powered, a Class II (moderate risk) device regulated under 21 CFR 872.4475.