ACCUMESH DEPLOYMENT SYSTEM

Mesh, Surgical, Deployer

Covidien LLC

The following data is part of a premarket notification filed by Covidien Llc with the FDA for Accumesh Deployment System.

Pre-market Notification Details

Device IDK123066
510k NumberK123066
Device Name:ACCUMESH DEPLOYMENT SYSTEM
ClassificationMesh, Surgical, Deployer
Applicant Covidien LLC 15 CROSBY DRIVE Bedford,  MA  01730
ContactElizabeth Mcmeniman
CorrespondentElizabeth Mcmeniman
Covidien LLC 15 CROSBY DRIVE Bedford,  MA  01730
Product CodeORQ  
CFR Regulation Number878.3300 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2012-10-01
Decision Date2012-10-16
Summary:summary

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