Cleared Traditional

K090959 - LECTRAJET NEEDLE-FREE INJECTION SYSTEM, MODEL: M3 RA
(FDA 510(k) Clearance)

K090959 · D'Antonio Consultants International, Inc. (Dci) · General Hospital
Dec 2009
Decision
262d
Days
Class 2
Risk

K090959 is an FDA 510(k) clearance for the LECTRAJET NEEDLE-FREE INJECTION SYSTEM, MODEL: M3 RA, a Injector, Fluid, Non-electrically Powered (Class II — Special Controls, product code KZE), submitted by D'Antonio Consultants International, Inc. (Dci) (East Syracuse, US). The FDA issued a Cleared decision on December 24, 2009, 262 days after receiving the submission on April 6, 2009. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5430.

Submission Details

510(k) Number K090959 FDA.gov
FDA Decision Cleared SESE
Date Received April 06, 2009
Decision Date December 24, 2009
Days to Decision 262 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF

Device Classification

Product Code KZE — Injector, Fluid, Non-electrically Powered
Device Class Class II — Special Controls
CFR Regulation 21 CFR 880.5430

Similar Devices — KZE Injector, Fluid, Non-electrically Powered

All 52
BIOJECT NEEDLE-FREE INJECTION MANAGEMENT SYSTEM
K121270 · Bioject Medical Technologies, Inc. · Jul 2012
PHARMAJET STRATIS 0.5 ML NEEDLE-FREE INJECTION SYSTEM MODEL 501-01, STRATIS INJECTOR CATALOG 501-10, STRATIS RESET STATI
K111517 · Pharmajet, Inc. · Jul 2011
PHARMAJET 0.1 ML INTRADERMAL NEEDLE-FREE INJECTION SYSTEM
K110456 · Pharmajet, Inc. · Mar 2011
ZETAJET
K090003 · Bioject, Inc. · Apr 2009
PHARMAJET NEEDLE-FREE INJECTION SYSTEM
K081532 · Pharmajet, Inc. · Feb 2009
AIRGENT, MODEL AG7000010
K082138 · Perfaction, Inc. · Jan 2009