PARIETEX COMPOSITE VENTRAL PATCH

Mesh, Surgical, Polymeric

SOFRADIM PRODUCTION

The following data is part of a premarket notification filed by Sofradim Production with the FDA for Parietex Composite Ventral Patch.

Pre-market Notification Details

Device IDK120506
510k NumberK120506
Device Name:PARIETEX COMPOSITE VENTRAL PATCH
ClassificationMesh, Surgical, Polymeric
Applicant SOFRADIM PRODUCTION 15 CROSBY DR Bedford,  MA  01730
ContactJames Mcmahon
CorrespondentJames Mcmahon
SOFRADIM PRODUCTION 15 CROSBY DR Bedford,  MA  01730
Product CodeFTL  
CFR Regulation Number878.3300 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2012-02-21
Decision Date2012-06-13
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
10884521165724 K120506 000
10884521514164 K120506 000
10884521514157 K120506 000
10884521514140 K120506 000
10884521165717 K120506 000
10884521165700 K120506 000

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