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 |