Cleared Traditional

IQ CHAMBERS

K992553 · Dormer Laboratories, Inc. · General Hospital
Apr 2000
Decision
257d
Days
Class 1
Risk

About This 510(k) Submission

K992553 is an FDA 510(k) clearance for the IQ CHAMBERS, a Applicator, Absorbent Tipped, Non-sterile (Class I — General Controls, product code KXF), submitted by Dormer Laboratories, Inc. (Washington, US). The FDA issued a Cleared decision on April 12, 2000, 257 days after receiving the submission on July 30, 1999. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.6025.

Submission Details

510(k) Number K992553 FDA.gov
FDA Decision Cleared SESE
Date Received July 30, 1999
Decision Date April 12, 2000
Days to Decision 257 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF

Device Classification

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