Cleared Traditional

CORNING DISPOSABLE ROLLER BOTTLES

K872076 · Corning Medical & Scientific · Pathology
Jun 1987
Decision
17d
Days
Class 1
Risk

About This 510(k) Submission

K872076 is an FDA 510(k) clearance for the CORNING DISPOSABLE ROLLER BOTTLES, a Apparatus, Roller (Class I — General Controls, product code KJB), submitted by Corning Medical & Scientific (Oneonta, US). The FDA issued a Cleared decision on June 15, 1987, 17 days after receiving the submission on May 29, 1987. This device falls under the Pathology review panel. Regulated under 21 CFR 864.2240.

Submission Details

510(k) Number K872076 FDA.gov
FDA Decision Cleared SESE
Date Received May 29, 1987
Decision Date June 15, 1987
Days to Decision 17 days
Submission Type Traditional
Review Panel Pathology (PA)
Summary

Device Classification

Product Code KJB — Apparatus, Roller
Device Class Class I — General Controls
CFR Regulation 21 CFR 864.2240