Cleared Traditional

MACAN MODEL MC-4A DENTAL ELECTROSURGICAL UNIT

K052622 · Macan Engineering Co. · Dental
Dec 2005
Decision
77d
Days
Class 2
Risk

About This 510(k) Submission

K052622 is an FDA 510(k) clearance for the MACAN MODEL MC-4A DENTAL ELECTROSURGICAL UNIT, 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 December 9, 2005, 77 days after receiving the submission on September 23, 2005. This device falls under the Dental review panel. Regulated under 21 CFR 872.4920.

Submission Details

510(k) Number K052622 FDA.gov
FDA Decision Cleared SESE
Date Received September 23, 2005
Decision Date December 09, 2005
Days to Decision 77 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF

Device Classification

Product Code EKZ — Unit, Electrosurgical, And Accessories, Dental
Device Class Class II — Special Controls
CFR Regulation 21 CFR 872.4920