Cleared Traditional

THORA-KLEX 350 ML PEDIATRIC CHEST DRAINAGE SYSTEM

K932327 · Davol, Inc. · General Hospital
Jul 1993
Decision
61d
Days
Class 2
Risk

About This 510(k) Submission

K932327 is an FDA 510(k) clearance for the THORA-KLEX 350 ML PEDIATRIC CHEST DRAINAGE SYSTEM, a Bottle, Collection, Vacuum (Class II — Special Controls, product code KDQ), submitted by Davol, Inc. (Cranston, US). The FDA issued a Cleared decision on July 13, 1993, 61 days after receiving the submission on May 13, 1993. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.6740.

Submission Details

510(k) Number K932327 FDA.gov
FDA Decision Cleared SESE
Date Received May 13, 1993
Decision Date July 13, 1993
Days to Decision 61 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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