Cleared Traditional

MILLICORE AB DIGIVENT CHEST DRAINAGE SYSTEM

K062302 · Millicore AB · General Hospital
Oct 2006
Decision
59d
Days
Class 2
Risk

About This 510(k) Submission

K062302 is an FDA 510(k) clearance for the MILLICORE AB DIGIVENT CHEST DRAINAGE SYSTEM, a Bottle, Collection, Vacuum (Class II — Special Controls, product code KDQ), submitted by Millicore AB (North Attleboro, US). The FDA issued a Cleared decision on October 6, 2006, 59 days after receiving the submission on August 8, 2006. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.6740.

Submission Details

510(k) Number K062302 FDA.gov
FDA Decision Cleared SESE
Date Received August 08, 2006
Decision Date October 06, 2006
Days to Decision 59 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF

Device Classification

Product Code KDQ — Bottle, Collection, Vacuum
Device Class Class II — Special Controls
CFR Regulation 21 CFR 880.6740

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