Cleared Traditional

COOL.CLICK

K050734 · Bioject, Inc. · General Hospital
Jun 2005
Decision
74d
Days
Class 2
Risk

About This 510(k) Submission

K050734 is an FDA 510(k) clearance for the COOL.CLICK, 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 June 3, 2005, 74 days after receiving the submission on March 21, 2005. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5430.

Submission Details

510(k) Number K050734 FDA.gov
FDA Decision Cleared SESE
Date Received March 21, 2005
Decision Date June 03, 2005
Days to Decision 74 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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