Cleared Traditional

K912445 - MEGA CONTINUOUS EPIDURAL ANESTHESIA KIT
(FDA 510(k) Clearance)

K912445 · Mega Medical, Inc. · Anesthesiology

Oct 1991

Decision

137d

Days

Class 2

Risk

K912445 is an FDA 510(k) clearance for the MEGA CONTINUOUS EPIDURAL ANESTHESIA KIT, a Anesthesia Conduction Kit (Class II — Special Controls, product code CAZ), submitted by Mega Medical, Inc. (Tampa, US). The FDA issued a Cleared decision on October 18, 1991, 137 days after receiving the submission on June 3, 1991. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5140.

Submission Details

510(k) Number	K912445 FDA.gov
FDA Decision	Cleared SESE
Date Received	June 03, 1991
Decision Date	October 18, 1991
Days to Decision	137 days
Submission Type	Traditional
Review Panel	Anesthesiology (AN)
Summary	Statement

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.