Cleared Traditional

KENDALL SAFETAP SPINAL ANESTHESIA TRAY

K953766 · Kendall Healthcare Products Co. Div.Of Tyco Health · Anesthesiology
Nov 1995
Decision
102d
Days
Class 2
Risk

About This 510(k) Submission

K953766 is an FDA 510(k) clearance for the KENDALL SAFETAP SPINAL ANESTHESIA TRAY, a Anesthesia Conduction Kit (Class II — Special Controls, product code CAZ), submitted by Kendall Healthcare Products Co. Div.Of Tyco Health (Mansfield, US). The FDA issued a Cleared decision on November 24, 1995, 102 days after receiving the submission on August 14, 1995. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5140.

Submission Details

510(k) Number K953766 FDA.gov
FDA Decision Cleared SESK
Date Received August 14, 1995
Decision Date November 24, 1995
Days to Decision 102 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.