The following data is part of a premarket notification filed by Rosch Ag Medizintechnic with the FDA for Injex Needle-free Injection System; Rojex Needle-free Injection System.
| Device ID | K020786 |
| 510k Number | K020786 |
| Device Name: | INJEX NEEDLE-FREE INJECTION SYSTEM; ROJEX NEEDLE-FREE INJECTION SYSTEM |
| Classification | Injector, Fluid, Non-electrically Powered |
| Applicant | ROSCH AG MEDIZINTECHNIC BUCKOWER DAMM 114 Berlin, DE D-12349 |
| Contact | Kerstin Zalewski |
| Product Code | KZE |
| CFR Regulation Number | 880.5430 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2002-03-11 |
| Decision Date | 2002-09-25 |
| Summary: | summary |