Cleared Traditional

CONTINENT STOMA SYSTEM & ACCESSORIES

K844186 · Chesebrough-Pond'S U.S.A. Co. · Ear, Nose, Throat
Jan 1985
Decision
78d
Days
Class 1
Risk

About This 510(k) Submission

K844186 is an FDA 510(k) clearance for the CONTINENT STOMA SYSTEM & ACCESSORIES, a Trocar, Sinus (Class I — General Controls, product code KBG), submitted by Chesebrough-Pond'S U.S.A. Co. (Greenwich, US). The FDA issued a Cleared decision on January 15, 1985, 78 days after receiving the submission on October 29, 1984. This device falls under the Ear, Nose, Throat review panel. Regulated under 21 CFR 874.4420.

Submission Details

510(k) Number K844186 FDA.gov
FDA Decision Cleared SESE
Date Received October 29, 1984
Decision Date January 15, 1985
Days to Decision 78 days
Submission Type Traditional
Review Panel Ear, Nose, Throat (EN)
Summary —

Device Classification

Product Code KBG — Trocar, Sinus
Device Class Class I — General Controls
CFR Regulation 21 CFR 874.4420