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 IDK121139
510k NumberK121139
Device Name:ACCUMESH DEPLOYMENT SYSTEM
ClassificationMesh, Surgical, Deployer
Applicant Covidien LLC 15 CROSBY DR Bedford,  MA  01730
ContactJames Mcmahon
CorrespondentJames Mcmahon
Covidien LLC 15 CROSBY DR Bedford,  MA  01730
Product CodeORQ  
CFR Regulation Number878.3300 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2012-04-16
Decision Date2012-05-02
Summary:summary

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.