Cleared Traditional

K073369 - EI DOWNPAK BARRIER SLEEVES
(FDA 510(k) Clearance)

K073369 · Hu-Friedy Mfg. Co., Inc. · Dental
Feb 2008
Decision
89d
Days
Class 1
Risk

K073369 is an FDA 510(k) clearance for the EI DOWNPAK BARRIER SLEEVES, a Gutta-percha (Class I — General Controls, product code EKM), submitted by Hu-Friedy Mfg. Co., Inc. (Chicago, US). The FDA issued a Cleared decision on February 27, 2008, 89 days after receiving the submission on November 30, 2007. This device falls under the Dental review panel. Regulated under 21 CFR 872.3850.

Submission Details

510(k) Number K073369 FDA.gov
FDA Decision Cleared SESE
Date Received November 30, 2007
Decision Date February 27, 2008
Days to Decision 89 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF

Device Classification

Product Code EKM — Gutta-percha
Device Class Class I — General Controls
CFR Regulation 21 CFR 872.3850