Cleared Special

ATRIUM CENTRILFX MESH

K110110 · Atrium Medical Corporation · General & Plastic Surgery
Feb 2011
Decision
32d
Days
Class 2
Risk

About This 510(k) Submission

K110110 is an FDA 510(k) clearance for the ATRIUM CENTRILFX MESH, a Mesh, Surgical, Polymeric (Class II — Special Controls, product code FTL), submitted by Atrium Medical Corporation (Hudson, US). The FDA issued a Cleared decision on February 15, 2011, 32 days after receiving the submission on January 14, 2011. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.3300.

Submission Details

510(k) Number K110110 FDA.gov
FDA Decision Cleared SESE
Date Received January 14, 2011
Decision Date February 15, 2011
Days to Decision 32 days
Submission Type Special
Review Panel General & Plastic Surgery (SU)
Summary Statement

Device Classification

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

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