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KZE — Injector, Fluid, Non-Electrically Powered Class II

FDA Device Classification

Classification Details

Product Code
KZE
Device Class
Class II
Regulation Number
880.5430
Submission Type
Review Panel
HO
Medical Specialty
General Hospital
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K121270bioject medical technologiesBIOJECT NEEDLE-FREE INJECTION MANAGEMENT SYSTEMJuly 19, 2012
K111517pharmajetPHARMAJET STRATIS 0.5 ML NEEDLE-FREE INJECTION SYSTEM MODEL 501-01, STRATIS INJEJuly 27, 2011
K110456pharmajetPHARMAJET 0.1 ML INTRADERMAL NEEDLE-FREE INJECTION SYSTEMMarch 2, 2011
K090959d'antonio consultants international, inc. (dci)LECTRAJET NEEDLE-FREE INJECTION SYSTEM, MODEL: M3 RADecember 24, 2009
K090003biojectZETAJETApril 2, 2009
K081532pharmajetPHARMAJET NEEDLE-FREE INJECTION SYSTEMFebruary 26, 2009
K082138perfactionAIRGENT, MODEL AG7000010January 23, 2009
K060819medical house products limitedCOOL.CLICK 2June 16, 2006
K051985biovalve technologiesBIOVALVE MINI-JECT NEEDLEFREE INJECTORAugust 17, 2005
K050734biojectCOOL.CLICKJune 3, 2005
K041239genesis medical technologyGENESIS MEDICAL TECHNOLOGIES, INC. PHARMAJET NEEDLE-FREE INJECTOR, MODEL M2000November 8, 2004
K041280felton internationalHUMAN SUBCUTANEOUS INJECTOR, MODEL HSI 500June 24, 2004
K032976biovalve technologiesBIOVALVE MINIJECT NEEDLE-FREE INJECTION SYSTEM, MODEL FG-01-001April 16, 2004
K024018avant medical corporationAVANT GUARDIAN 101January 17, 2003
K020786rosch ag medizintechnicINJEX NEEDLE-FREE INJECTION SYSTEM; ROJEX NEEDLE-FREE INJECTION SYSTEMSeptember 25, 2002
K022502equidyne systemsINJEX 30 NEEDLE FREE INJECTION SYSTEM, MODEL 100000September 5, 2002
K022148equidyne systemsINJEX 30 NEEDLE FREE INJECTION SYSTEMJuly 23, 2002
K013256felton internationalBI-3M NEEDLE-FREE INJECTOR SYSTEMDecember 7, 2001
K003741equidyne systemsJET SYRINGE MODEL-100500June 1, 2001
K003908biojectSEROJETMarch 8, 2001