Cleared Traditional

COLD CD ASP MODULE, ITE

K933041 · Electone, Inc. · General & Plastic Surgery

Aug 1993

Decision

96d

Days

Class 2

Risk

About This 510(k) Submission

K933041 is an FDA 510(k) clearance for the COLD CD ASP MODULE, ITE, a I.v. Start Kit (Class II — Special Controls, product code LRS), submitted by Electone, Inc. (Longwood, US). The FDA issued a Cleared decision on August 2, 1993, 96 days after receiving the submission on April 28, 1993. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 880.5200.

Submission Details

510(k) Number	K933041 FDA.gov
FDA Decision	Cleared SESE
Date Received	April 28, 1993
Decision Date	August 02, 1993
Days to Decision	96 days
Submission Type	Traditional
Review Panel	General & Plastic Surgery (SU)
Summary	Statement

Device Classification

Product Code	LRS — I.v. Start Kit
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 880.5200
Definition	This Product Code Has Been Established In Accordance With The May 20, 1997, Guidance Entitled, Convenience Kits Interim Regulatory Guidance, Found At Http://www.fda.gov/downloads/medicaldevices/deviceregulationandguidance/guidancedocuments/ucm080217.pdf. 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.