Cleared Traditional

DISPOSABLE STERILE SYRINGE FILTERS

K875122 · Corning Medical & Scientific · Pathology
Jan 1988
Decision
28d
Days
Class 1
Risk

About This 510(k) Submission

K875122 is an FDA 510(k) clearance for the DISPOSABLE STERILE SYRINGE FILTERS, a Filters, Cell Collection, Tissue Processing (Class I — General Controls, product code KET), submitted by Corning Medical & Scientific (Oneonta, US). The FDA issued a Cleared decision on January 12, 1988, 28 days after receiving the submission on December 15, 1987. This device falls under the Pathology review panel. Regulated under 21 CFR 864.3010.

Submission Details

510(k) Number K875122 FDA.gov
FDA Decision Cleared SESE
Date Received December 15, 1987
Decision Date January 12, 1988
Days to Decision 28 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