Cleared Traditional

ULTRA-FREE

K790445 · Millipore Corp. · Toxicology
Jun 1979
Decision
115d
Days
Class 1
Risk

About This 510(k) Submission

K790445 is an FDA 510(k) clearance for the ULTRA-FREE, a Unit, Filter, Membrane (Class I — General Controls, product code JRL), submitted by Millipore Corp. (Mchenry, US). The FDA issued a Cleared decision on June 28, 1979, 115 days after receiving the submission on March 5, 1979. This device falls under the Toxicology review panel. Regulated under 21 CFR 862.2050.

Submission Details

510(k) Number K790445 FDA.gov
FDA Decision Cleared SESE
Date Received March 05, 1979
Decision Date June 28, 1979
Days to Decision 115 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary —

Device Classification

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