Cleared Abbreviated

ZETAJET

K090003 · Bioject, Inc. · General Hospital
Apr 2009
Decision
90d
Days
Class 2
Risk

About This 510(k) Submission

K090003 is an FDA 510(k) clearance for the ZETAJET, a Injector, Fluid, Non-electrically Powered (Class II — Special Controls, product code KZE), submitted by Bioject, Inc. (Tualatin, US). The FDA issued a Cleared decision on April 2, 2009, 90 days after receiving the submission on January 2, 2009. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5430.

Submission Details

510(k) Number K090003 FDA.gov
FDA Decision Cleared SESE
Date Received January 02, 2009
Decision Date April 02, 2009
Days to Decision 90 days
Submission Type Abbreviated
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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