Cleared Traditional

MC6A

K050735 · Macan Engineering Co. · Dental

May 2005

Decision

63d

Days

Class 2

Risk

About This 510(k) Submission

K050735 is an FDA 510(k) clearance for the MC6A, a Unit, Electrosurgical, And Accessories, Dental (Class II — Special Controls, product code EKZ), submitted by Macan Engineering Co. (Chicago, US). The FDA issued a Cleared decision on May 23, 2005, 63 days after receiving the submission on March 21, 2005. This device falls under the Dental review panel. Regulated under 21 CFR 872.4920.

Submission Details

510(k) Number	K050735 FDA.gov
FDA Decision	Cleared SESE
Date Received	March 21, 2005
Decision Date	May 23, 2005
Days to Decision	63 days
Submission Type	Traditional
Review Panel	Dental (DE)
Summary	Summary PDF