Cleared Traditional

THE FUGO BLADE FOR DENTISTRY

K063468 · Medisurg , Ltd. · Dental
Apr 2007
Decision
153d
Days
Class 2
Risk

About This 510(k) Submission

K063468 is an FDA 510(k) clearance for the THE FUGO BLADE FOR DENTISTRY, a Unit, Electrosurgical, And Accessories, Dental (Class II — Special Controls, product code EKZ), submitted by Medisurg , Ltd. (Norristown, US). The FDA issued a Cleared decision on April 18, 2007, 153 days after receiving the submission on November 16, 2006. This device falls under the Dental review panel. Regulated under 21 CFR 872.4920.

Submission Details

510(k) Number K063468 FDA.gov
FDA Decision Cleared SESE
Date Received November 16, 2006
Decision Date April 18, 2007
Days to Decision 153 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