Cleared Traditional

CLICKER

K994384 · Bioject, Inc. · General Hospital
Jun 2000
Decision
177d
Days
Class 2
Risk

About This 510(k) Submission

K994384 is an FDA 510(k) clearance for the CLICKER, 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 22, 2000, 177 days after receiving the submission on December 28, 1999. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5430.

Submission Details

510(k) Number K994384 FDA.gov
FDA Decision Cleared SESE
Date Received December 28, 1999
Decision Date June 22, 2000
Days to Decision 177 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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