Cleared Traditional

ORWELL FLUID COLLECTION AND DISPOSAL SYSTEM

K080845 · Cardinalhealth · General & Plastic Surgery
Apr 2008
Decision
35d
Days
Class 2
Risk

About This 510(k) Submission

K080845 is an FDA 510(k) clearance for the ORWELL FLUID COLLECTION AND DISPOSAL SYSTEM, a Apparatus, Suction, Ward Use, Portable, Ac-powered (Class II — Special Controls, product code JCX), submitted by Cardinalhealth (Mcgaw Park, US). The FDA issued a Cleared decision on April 30, 2008, 35 days after receiving the submission on March 26, 2008. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.4780.

Submission Details

510(k) Number K080845 FDA.gov
FDA Decision Cleared SESE
Date Received March 26, 2008
Decision Date April 30, 2008
Days to Decision 35 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF

Device Classification

Product Code JCX — Apparatus, Suction, Ward Use, Portable, Ac-powered
Device Class Class II — Special Controls
CFR Regulation 21 CFR 878.4780

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