Cleared Traditional

VACUSHIELD TM

K813159 · Gelman Sciences, Inc. · Chemistry
Dec 1981
Decision
22d
Days
Class 1
Risk

About This 510(k) Submission

K813159 is an FDA 510(k) clearance for the VACUSHIELD TM, a Unit, Filter, Membrane (Class I — General Controls, product code JRL), submitted by Gelman Sciences, Inc. (Mchenry, US). The FDA issued a Cleared decision on December 8, 1981, 22 days after receiving the submission on November 16, 1981. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.2050.

Submission Details

510(k) Number K813159 FDA.gov
FDA Decision Cleared SESE
Date Received November 16, 1981
Decision Date December 08, 1981
Days to Decision 22 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary —

Device Classification

Product Code JRL — Unit, Filter, Membrane
Device Class Class I — General Controls
CFR Regulation 21 CFR 862.2050