Cleared Traditional

K001129 - PROLONG, MODELS PL50, PL100, PL150
(FDA 510(k) Clearance)

K001129 · Life-Tech Intl., Inc. · Anesthesiology

Jul 2000

Decision

90d

Days

Class 2

Risk

K001129 is an FDA 510(k) clearance for the PROLONG, MODELS PL50, PL100, PL150. This device is classified as a Anesthesia Conduction Kit (Class II — Special Controls, product code CAZ).

Submitted by Life-Tech Intl., Inc. (Stafford, US). The FDA issued a Cleared decision on July 6, 2000, 90 days after receiving the submission on April 7, 2000.

This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 868.5140. 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..

Submission Details

510(k) Number	K001129 FDA.gov
FDA Decision	Cleared SESE
Date Received	April 07, 2000
Decision Date	July 06, 2000
Days to Decision	90 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.