GENESIS MEDICAL TECHNOLOGIES, INC. PHARMAJET NEEDLE-FREE INJECTOR, MODEL M2000

Injector, Fluid, Non-electrically Powered

GENESIS MEDICAL TECHNOLOGY, INC.

The following data is part of a premarket notification filed by Genesis Medical Technology, Inc. with the FDA for Genesis Medical Technologies, Inc. Pharmajet Needle-free Injector, Model M2000.

Pre-market Notification Details

Device IDK041239
510k NumberK041239
Device Name:GENESIS MEDICAL TECHNOLOGIES, INC. PHARMAJET NEEDLE-FREE INJECTOR, MODEL M2000
ClassificationInjector, Fluid, Non-electrically Powered
Applicant GENESIS MEDICAL TECHNOLOGY, INC. 1555 EAST FLAMINGO ROAD SUITE 155 Las Vegas,  NV  89119
ContactThomas Kroenke
CorrespondentThomas Kroenke
GENESIS MEDICAL TECHNOLOGY, INC. 1555 EAST FLAMINGO ROAD SUITE 155 Las Vegas,  NV  89119
Product CodeKZE  
CFR Regulation Number880.5430 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2004-05-11
Decision Date2004-11-08
Summary:summary

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