Cleared Traditional

SUTURE REMOVAL KIT

K941465 · Clinical Resources, Inc. · General & Plastic Surgery

Apr 1994

Decision

25d

Days

Class 1

Risk

About This 510(k) Submission

K941465 is an FDA 510(k) clearance for the SUTURE REMOVAL KIT, a Suture Removal Kit (Class I — General Controls, product code MCZ), submitted by Clinical Resources, Inc. (Elgin, US). The FDA issued a Cleared decision on April 22, 1994, 25 days after receiving the submission on March 28, 1994. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.4800.

Submission Details

510(k) Number	K941465 FDA.gov
FDA Decision	Cleared SESE
Date Received	March 28, 1994
Decision Date	April 22, 1994
Days to Decision	25 days
Submission Type	Traditional
Review Panel	General & Plastic Surgery (SU)
Summary	Statement

Device Classification

Product Code	MCZ — Suture Removal Kit
Device Class	Class I — General Controls
CFR Regulation	21 CFR 878.4800
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.