Cleared Traditional

K021585 - STELLAR SERIES SURGICAL LIGHTS WITH HERMES
(FDA 510(k) Clearance)

K021585 · Skytron, Div. the Kmw Group, Inc. · General & Plastic Surgery

Nov 2002

Decision

183d

Days

Class 2

Risk

K021585 is an FDA 510(k) clearance for the STELLAR SERIES SURGICAL LIGHTS WITH HERMES, 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 November 13, 2002, 183 days after receiving the submission on May 14, 2002. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.4580.

Submission Details

510(k) Number	K021585 FDA.gov
FDA Decision	Cleared SESE
Date Received	May 14, 2002
Decision Date	November 13, 2002
Days to Decision	183 days
Submission Type	Traditional
Review Panel	General & Plastic Surgery (SU)
Summary	Statement