Cleared Traditional

K960373 - BIOJECTOR 2000 MODEL 1B02000
(FDA 510(k) Clearance)

K960373 · Bioject, Inc. · General Hospital
Mar 1997
Decision
404d
Days
Class 2
Risk

K960373 is an FDA 510(k) clearance for the BIOJECTOR 2000 MODEL 1B02000, 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 March 5, 1997, 404 days after receiving the submission on January 26, 1996. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5430.

Submission Details

510(k) Number K960373 FDA.gov
FDA Decision Cleared SESE
Date Received January 26, 1996
Decision Date March 05, 1997
Days to Decision 404 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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