Cleared Traditional

LOWER EXTREMITY SUPPORT SYSTEM-LESS

K810433 · Walgen Medical Innoventions · General & Plastic Surgery

Mar 1981

Decision

22d

Days

Class 1

Risk

About This 510(k) Submission

K810433 is an FDA 510(k) clearance for the LOWER EXTREMITY SUPPORT SYSTEM-LESS, a Operating Room Accessories Table Tray (Class I — General Controls, product code FWZ), submitted by Walgen Medical Innoventions (Mchenry, US). The FDA issued a Cleared decision on March 13, 1981, 22 days after receiving the submission on February 19, 1981. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.4950.

Submission Details

510(k) Number	K810433 FDA.gov
FDA Decision	Cleared SESE
Date Received	February 19, 1981
Decision Date	March 13, 1981
Days to Decision	22 days
Submission Type	Traditional
Review Panel	General & Plastic Surgery (SU)
Summary	—

Device Classification

Product Code	FWZ — Operating Room Accessories Table Tray
Device Class	Class I — General Controls
CFR Regulation	21 CFR 878.4950
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.