Cleared Traditional

BIOJECT JET INJECTION SYSTEM

K920631 · Bioject, Inc. · General Hospital
Jun 1994
Decision
867d
Days
Class 2
Risk

About This 510(k) Submission

K920631 is an FDA 510(k) clearance for the BIOJECT JET INJECTION SYSTEM, a Injector, Fluid, Non-electrically Powered (Class II — Special Controls, product code KZE), submitted by Bioject, Inc. (Portland, US). The FDA issued a Cleared decision on June 28, 1994, 867 days after receiving the submission on February 12, 1992. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5430.

Submission Details

510(k) Number K920631 FDA.gov
FDA Decision Cleared SESE
Date Received February 12, 1992
Decision Date June 28, 1994
Days to Decision 867 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Statement

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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