Cleared Special

SURGICAL LIGHT HANDLE COVER

K133554 · Microtek Medical, Inc. an Ecolab Company · General & Plastic Surgery

Apr 2014

Decision

140d

Days

Class 2

Risk

About This 510(k) Submission

K133554 is an FDA 510(k) clearance for the SURGICAL LIGHT HANDLE COVER, a Light, Surgical, Accessories (Class II — Special Controls, product code FTA), submitted by Microtek Medical, Inc. an Ecolab Company (Saint Paul, US). The FDA issued a Cleared decision on April 8, 2014, 140 days after receiving the submission on November 19, 2013. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.4580.

Submission Details

510(k) Number	K133554 FDA.gov
FDA Decision	Cleared SESE
Date Received	November 19, 2013
Decision Date	April 08, 2014
Days to Decision	140 days
Submission Type	Special
Review Panel	General & Plastic Surgery (SU)
Summary	Summary PDF