Cleared Traditional

UNICOR, INC. CONNECTORS & AIRWAY EXTENSIONS

K953786 · Unicor, Inc. · Anesthesiology
Sep 1995
Decision
36d
Days
Class 1
Risk

About This 510(k) Submission

K953786 is an FDA 510(k) clearance for the UNICOR, INC. CONNECTORS & AIRWAY EXTENSIONS, a Connector, Airway (extension) (Class I — General Controls, product code BZA), submitted by Unicor, Inc. (Cleveland, US). The FDA issued a Cleared decision on September 19, 1995, 36 days after receiving the submission on August 14, 1995. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5810.

Submission Details

510(k) Number K953786 FDA.gov
FDA Decision Cleared SESE
Date Received August 14, 1995
Decision Date September 19, 1995
Days to Decision 36 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Statement

Device Classification

Product Code BZA — Connector, Airway (extension)
Device Class Class I — General Controls
CFR Regulation 21 CFR 868.5810