Cleared Traditional

PHARMAJET NEEDLE-FREE INJECTION SYSTEM

K081532 · Pharmajet, Inc. · General Hospital
Feb 2009
Decision
269d
Days
Class 2
Risk

About This 510(k) Submission

K081532 is an FDA 510(k) clearance for the PHARMAJET NEEDLE-FREE INJECTION SYSTEM, a Injector, Fluid, Non-electrically Powered (Class II — Special Controls, product code KZE), submitted by Pharmajet, Inc. (Golden, US). The FDA issued a Cleared decision on February 26, 2009, 269 days after receiving the submission on June 2, 2008. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5430.

Submission Details

510(k) Number K081532 FDA.gov
FDA Decision Cleared SESE
Date Received June 02, 2008
Decision Date February 26, 2009
Days to Decision 269 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

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