Cleared Traditional

K071698 - AURORA LED SERIES SURGICAL LIGHTS
(FDA 510(k) Clearance)

K071698 · Skytron, Div. the Kmw Group, Inc. · General & Plastic Surgery

Jul 2007

Decision

15d

Days

Class 2

Risk

K071698 is an FDA 510(k) clearance for the AURORA LED SERIES SURGICAL LIGHTS, a Light, Surgical, Ceiling Mounted (Class II — Special Controls, product code FSY), submitted by Skytron, Div. the Kmw Group, Inc. (Grand Rapids, US). The FDA issued a Cleared decision on July 6, 2007, 15 days after receiving the submission on June 21, 2007. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.4580.

Submission Details

510(k) Number	K071698 FDA.gov
FDA Decision	Cleared SESE
Date Received	June 21, 2007
Decision Date	July 06, 2007
Days to Decision	15 days
Submission Type	Traditional
Review Panel	General & Plastic Surgery (SU)
Summary	Summary PDF