Cleared Traditional

MEDCARE REGIONAL ANETHESIA KIT

K961075 · Medcare Medical Group, Inc. · Anesthesiology

Sep 1996

Decision

172d

Days

Class 2

Risk

About This 510(k) Submission

K961075 is an FDA 510(k) clearance for the MEDCARE REGIONAL ANETHESIA KIT, a Anesthesia Conduction Kit (Class II — Special Controls, product code CAZ), submitted by Medcare Medical Group, Inc. (East Swanzey, US). The FDA issued a Cleared decision on September 6, 1996, 172 days after receiving the submission on March 18, 1996. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5140.

Submission Details

510(k) Number	K961075 FDA.gov
FDA Decision	Cleared SEKD
Date Received	March 18, 1996
Decision Date	September 06, 1996
Days to Decision	172 days
Submission Type	Traditional
Review Panel	Anesthesiology (AN)
Summary	Summary PDF

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.