Cleared Traditional

PLEUR-EVAC SAHARA ADULT/PEDIATRIC CHEST DRAINAGE SYSTEM MODEL S-1100, S-1200, 2-2100, AND S-2200 WITH MODEL S-100 AUTOTR

K962856 · Deknatel, Inc. · General Hospital
Aug 1996
Decision
37d
Days
Class 2
Risk

About This 510(k) Submission

K962856 is an FDA 510(k) clearance for the PLEUR-EVAC SAHARA ADULT/PEDIATRIC CHEST DRAINAGE SYSTEM MODEL S-1100, S-1200, 2-2100, AND S-2200 WITH MODEL S-100 AUTOTR, a Bottle, Collection, Vacuum (Class II — Special Controls, product code KDQ), submitted by Deknatel, Inc. (Fall River, US). The FDA issued a Cleared decision on August 28, 1996, 37 days after receiving the submission on July 22, 1996. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.6740.

Submission Details

510(k) Number K962856 FDA.gov
FDA Decision Cleared SESE
Date Received July 22, 1996
Decision Date August 28, 1996
Days to Decision 37 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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