Cleared Traditional

CEMENT FUME EVACUATOR TANK & FILTER

K810542 · Walgen Medical Innoventions · Orthopedic

Mar 1981

Decision

14d

Days

Class 1

Risk

About This 510(k) Submission

K810542 is an FDA 510(k) clearance for the CEMENT FUME EVACUATOR TANK & FILTER, a Evacuator, Vapor, Cement Monomer (Class I — General Controls, product code JDY), submitted by Walgen Medical Innoventions (Mchenry, US). The FDA issued a Cleared decision on March 13, 1981, 14 days after receiving the submission on February 27, 1981. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.4220.

Submission Details

510(k) Number	K810542 FDA.gov
FDA Decision	Cleared SESE
Date Received	February 27, 1981
Decision Date	March 13, 1981
Days to Decision	14 days
Submission Type	Traditional
Review Panel	Orthopedic (OR)
Summary	—