Cleared Traditional

DISPOSABLE SYRINGE FILTERS

K840556 · Corning Medical & Scientific · Pathology
Mar 1984
Decision
26d
Days
Class 1
Risk

About This 510(k) Submission

K840556 is an FDA 510(k) clearance for the DISPOSABLE SYRINGE FILTERS, a Filters, Cell Collection, Tissue Processing (Class I — General Controls, product code KET), submitted by Corning Medical & Scientific (Mchenry, US). The FDA issued a Cleared decision on March 5, 1984, 26 days after receiving the submission on February 8, 1984. This device falls under the Pathology review panel. Regulated under 21 CFR 864.3010.

Submission Details

510(k) Number K840556 FDA.gov
FDA Decision Cleared SESE
Date Received February 08, 1984
Decision Date March 05, 1984
Days to Decision 26 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