Cleared Traditional

MAXI CABINET OPTIONAL BUILT IN S6000 LIGHT SOURCE

K911901 · Stortz · Ear, Nose, Throat

Jul 1991

Decision

88d

Days

Class 1

Risk

About This 510(k) Submission

K911901 is an FDA 510(k) clearance for the MAXI CABINET OPTIONAL BUILT IN S6000 LIGHT SOURCE, a Unit, Examining/treatment, Ent (Class I — General Controls, product code ETF), submitted by Stortz (Saint Louis, US). The FDA issued a Cleared decision on July 26, 1991, 88 days after receiving the submission on April 29, 1991. This device falls under the Ear, Nose, Throat review panel. Regulated under 21 CFR 874.5300.

Submission Details

510(k) Number	K911901 FDA.gov
FDA Decision	Cleared SESE
Date Received	April 29, 1991
Decision Date	July 26, 1991
Days to Decision	88 days
Submission Type	Traditional
Review Panel	Ear, Nose, Throat (EN)
Summary	Statement