Cleared Traditional

LPG 5/10, LPG 10/5, LPG 10/15 AND LPG 15/10

K940749 · Aalba Dent, Inc. · Dental
Mar 1994
Decision
38d
Days
Class 2
Risk

About This 510(k) Submission

K940749 is an FDA 510(k) clearance for the LPG 5/10, LPG 10/5, LPG 10/15 AND LPG 15/10, a Alloy, Metal, Base (Class II — Special Controls, product code EJH), submitted by Aalba Dent, Inc. (Chicago, US). The FDA issued a Cleared decision on March 28, 1994, 38 days after receiving the submission on February 18, 1994. This device falls under the Dental review panel. Regulated under 21 CFR 872.3710.

Submission Details

510(k) Number K940749 FDA.gov
FDA Decision Cleared SESE
Date Received February 18, 1994
Decision Date March 28, 1994
Days to Decision 38 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Statement

Device Classification

Product Code EJH — Alloy, Metal, Base
Device Class Class II — Special Controls
CFR Regulation 21 CFR 872.3710