Cleared Traditional

PHARMAJET 0.1 ML INTRADERMAL NEEDLE-FREE INJECTION SYSTEM

K110456 · Pharmajet, Inc. · General Hospital
Mar 2011
Decision
14d
Days
Class 2
Risk

About This 510(k) Submission

K110456 is an FDA 510(k) clearance for the PHARMAJET 0.1 ML INTRADERMAL 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 March 2, 2011, 14 days after receiving the submission on February 16, 2011. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5430.

Submission Details

510(k) Number K110456 FDA.gov
FDA Decision Cleared SESE
Date Received February 16, 2011
Decision Date March 02, 2011
Days to Decision 14 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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