Cleared Special

MACH LED 2SC

K140460 · Dr. Mach GmbH & Co. KG · General & Plastic Surgery

Apr 2014

Decision

38d

Days

Class 2

Risk

About This 510(k) Submission

K140460 is an FDA 510(k) clearance for the MACH LED 2SC, a Light, Surgical, Ceiling Mounted (Class II — Special Controls, product code FSY), submitted by Dr. Mach GmbH & Co. KG (Norderstedt, Schleswig-Holstein, DE). The FDA issued a Cleared decision on April 3, 2014, 38 days after receiving the submission on February 24, 2014. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.4580.

Submission Details

510(k) Number	K140460 FDA.gov
FDA Decision	Cleared SESE
Date Received	February 24, 2014
Decision Date	April 03, 2014
Days to Decision	38 days
Submission Type	Special
Review Panel	General & Plastic Surgery (SU)
Summary	Summary PDF