Cleared Special

PHARMAJET STRATIS 0.5 ML NEEDLE-FREE INJECTION SYSTEM MODEL 501-01, STRATIS INJECTOR CATALOG 501-10, STRATIS RESET STATI

K111517 · Pharmajet, Inc. · General Hospital
Jul 2011
Decision
55d
Days
Class 2
Risk

About This 510(k) Submission

K111517 is an FDA 510(k) clearance for the PHARMAJET STRATIS 0.5 ML NEEDLE-FREE INJECTION SYSTEM MODEL 501-01, STRATIS INJECTOR CATALOG 501-10, STRATIS RESET STATI, 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 July 27, 2011, 55 days after receiving the submission on June 2, 2011. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5430.

Submission Details

510(k) Number K111517 FDA.gov
FDA Decision Cleared SESE
Date Received June 02, 2011
Decision Date July 27, 2011
Days to Decision 55 days
Submission Type Special
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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