Cleared Traditional

CORNING DISPOSAL STERILE FILTER SYSTEM-NYLON

K844671 · Corning Medical & Scientific · Pathology
Feb 1985
Decision
87d
Days
Class 1
Risk

About This 510(k) Submission

K844671 is an FDA 510(k) clearance for the CORNING DISPOSAL STERILE FILTER SYSTEM-NYLON, a Filters, Cell Collection, Tissue Processing (Class I — General Controls, product code KET), submitted by Corning Medical & Scientific (Medfield, US). The FDA issued a Cleared decision on February 25, 1985, 87 days after receiving the submission on November 30, 1984. This device falls under the Pathology review panel. Regulated under 21 CFR 864.3010.

Submission Details

510(k) Number K844671 FDA.gov
FDA Decision Cleared SESE
Date Received November 30, 1984
Decision Date February 25, 1985
Days to Decision 87 days
Submission Type Traditional
Review Panel Pathology (PA)
Summary —

Device Classification

Product Code KET — Filters, Cell Collection, Tissue Processing
Device Class Class I — General Controls
CFR Regulation 21 CFR 864.3010