PARIETEX OPTIMIZED COMPOSTIE MESH

Mesh, Surgical, Polymeric

SOFRADIM PRODUCTION

The following data is part of a premarket notification filed by Sofradim Production with the FDA for Parietex Optimized Compostie Mesh.

Pre-market Notification Details

Device IDK110815
510k NumberK110815
Device Name:PARIETEX OPTIMIZED COMPOSTIE MESH
ClassificationMesh, Surgical, Polymeric
Applicant SOFRADIM PRODUCTION BIOSURGERY 15 CROSBY DRIVE Bedford,  MA  01730
ContactJames Mcmahon
CorrespondentJames Mcmahon
SOFRADIM PRODUCTION BIOSURGERY 15 CROSBY DRIVE Bedford,  MA  01730
Product CodeFTL  
CFR Regulation Number878.3300 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2011-03-24
Decision Date2011-04-19
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
10884521179851 K110815 000
10884521179837 K110815 000
10884521179677 K110815 000
10884521179653 K110815 000
10884521179875 K110815 000
10884521179790 K110815 000
10884521179769 K110815 000
10884521179745 K110815 000
10884521179707 K110815 000

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