INJEX NEEDLE-FREE INJECTION SYSTEM; ROJEX NEEDLE-FREE INJECTION SYSTEM

Injector, Fluid, Non-electrically Powered

ROSCH AG MEDIZINTECHNIC

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.

Pre-market Notification Details

Device IDK020786
510k NumberK020786
Device Name:INJEX NEEDLE-FREE INJECTION SYSTEM; ROJEX NEEDLE-FREE INJECTION SYSTEM
ClassificationInjector, Fluid, Non-electrically Powered
Applicant ROSCH AG MEDIZINTECHNIC BUCKOWER DAMM 114 Berlin,  DE D-12349
ContactKerstin Zalewski
Product CodeKZE  
CFR Regulation Number880.5430 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedYes
Combination ProductNo
Date Received2002-03-11
Decision Date2002-09-25
Summary:summary

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