Cleared Special

PARIETEX OPTIMIZED COMPOSTIE MESH

K110815 · Sofradim Production · General & Plastic Surgery
Apr 2011
Decision
26d
Days
Class 2
Risk

About This 510(k) Submission

K110815 is an FDA 510(k) clearance for the PARIETEX OPTIMIZED COMPOSTIE MESH, a Mesh, Surgical, Polymeric (Class II — Special Controls, product code FTL), submitted by Sofradim Production (Bedford, US). The FDA issued a Cleared decision on April 19, 2011, 26 days after receiving the submission on March 24, 2011. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.3300.

Submission Details

510(k) Number K110815 FDA.gov
FDA Decision Cleared SESE
Date Received March 24, 2011
Decision Date April 19, 2011
Days to Decision 26 days
Submission Type Special
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF

Device Classification

Product Code FTL — Mesh, Surgical, Polymeric
Device Class Class II — Special Controls
CFR Regulation 21 CFR 878.3300

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