Cleared Traditional

SHILEY ELBOW 15MM SWIVEL CONNECTOR

K895388 · Shiley, Inc. · Anesthesiology
Oct 1989
Decision
58d
Days
Class 1
Risk

About This 510(k) Submission

K895388 is an FDA 510(k) clearance for the SHILEY ELBOW 15MM SWIVEL CONNECTOR, a Connector, Airway (extension) (Class I — General Controls, product code BZA), submitted by Shiley, Inc. (Irvine, US). The FDA issued a Cleared decision on October 27, 1989, 58 days after receiving the submission on August 30, 1989. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5810.

Submission Details

510(k) Number K895388 FDA.gov
FDA Decision Cleared SESE
Date Received August 30, 1989
Decision Date October 27, 1989
Days to Decision 58 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary —

Device Classification

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

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