Cleared Special

MEDICON 2.4 MANDIBULAR RECONSTRUCTION PLATING SYSTEM

K043297 · Medicon EG · Dental
Feb 2005
Decision
86d
Days
Class 2
Risk

About This 510(k) Submission

K043297 is an FDA 510(k) clearance for the MEDICON 2.4 MANDIBULAR RECONSTRUCTION PLATING SYSTEM, a Plate, Bone (Class II — Special Controls, product code JEY), submitted by Medicon EG (Amsterdam, NL). The FDA issued a Cleared decision on February 23, 2005, 86 days after receiving the submission on November 29, 2004. This device falls under the Dental review panel. Regulated under 21 CFR 872.4760.

Submission Details

510(k) Number K043297 FDA.gov
FDA Decision Cleared SESE
Date Received November 29, 2004
Decision Date February 23, 2005
Days to Decision 86 days
Submission Type Special
Review Panel Dental (DE)
Summary Summary PDF

Device Classification

Product Code JEY — Plate, Bone
Device Class Class II — Special Controls
CFR Regulation 21 CFR 872.4760

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