Cleared Traditional

MEGA SPINAL ANESTHESIA KIT

K912322 · Mega Medical, Inc. · Anesthesiology

Sep 1991

Decision

125d

Days

Class 2

Risk

About This 510(k) Submission

K912322 is an FDA 510(k) clearance for the MEGA SPINAL 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 September 26, 1991, 125 days after receiving the submission on May 24, 1991. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5140.

Submission Details

510(k) Number	K912322 FDA.gov
FDA Decision	Cleared SEKD
Date Received	May 24, 1991
Decision Date	September 26, 1991
Days to Decision	125 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.