Cleared Traditional

EPIDURAL ANESTHESIA TRAY

K860833 · Travenol Laboratories, S.A. · Anesthesiology

Apr 1986

Decision

43d

Days

Class 2

Risk

About This 510(k) Submission

K860833 is an FDA 510(k) clearance for the EPIDURAL ANESTHESIA TRAY, a Anesthesia Conduction Kit (Class II — Special Controls, product code CAZ), submitted by Travenol Laboratories, S.A. (Deerfield, US). The FDA issued a Cleared decision on April 17, 1986, 43 days after receiving the submission on March 5, 1986. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5140.

Submission Details

510(k) Number	K860833 FDA.gov
FDA Decision	Cleared SESE
Date Received	March 05, 1986
Decision Date	April 17, 1986
Days to Decision	43 days
Submission Type	Traditional
Review Panel	Anesthesiology (AN)
Summary	—

Device Classification

Product Code	CAZ — Anesthesia Conduction Kit
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 868.5140
Definition	This Product Code Has Been Established In Accordance With The May 20, 1997, Guidance Entitled, Convenience Kits Interim Regulatory Guidance, Found At Www.fda.gov/cdrh/ode/convkit.html. This Type Of Convenience Kit, As Listed In The Guidance Above, Is Under Enforcement Discretion, And Does Not Require A Premarket Notification (510(k)) To Market If It Meets All Criteria In The Guidance.