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.
Device ID | K041239 |
510k Number | K041239 |
Device Name: | GENESIS MEDICAL TECHNOLOGIES, INC. PHARMAJET NEEDLE-FREE INJECTOR, MODEL M2000 |
Classification | Injector, Fluid, Non-electrically Powered |
Applicant | GENESIS MEDICAL TECHNOLOGY, INC. 1555 EAST FLAMINGO ROAD SUITE 155 Las Vegas, NV 89119 |
Contact | Thomas Kroenke |
Correspondent | Thomas Kroenke GENESIS MEDICAL TECHNOLOGY, INC. 1555 EAST FLAMINGO ROAD SUITE 155 Las Vegas, NV 89119 |
Product Code | KZE |
CFR Regulation Number | 880.5430 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2004-05-11 |
Decision Date | 2004-11-08 |
Summary: | summary |