Cleared Traditional

ALLERGEAZE R CLEAR

K103409 · Smartpractice · General Hospital
Mar 2011
Decision
113d
Days
Class 1
Risk

About This 510(k) Submission

K103409 is an FDA 510(k) clearance for the ALLERGEAZE R CLEAR, a Applicator, Absorbent Tipped, Non-sterile (Class I — General Controls, product code KXF), submitted by Smartpractice (Phoenix, US). The FDA issued a Cleared decision on March 15, 2011, 113 days after receiving the submission on November 22, 2010. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.6025.

Submission Details

510(k) Number K103409 FDA.gov
FDA Decision Cleared SESE
Date Received November 22, 2010
Decision Date March 15, 2011
Days to Decision 113 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Statement

Device Classification

Product Code KXF — Applicator, Absorbent Tipped, Non-sterile
Device Class Class I — General Controls
CFR Regulation 21 CFR 880.6025