MODIFICATION TO PARIETEX COMPOSITE (PCO) MESH

Mesh, Surgical, Polymeric

SOFRADIM PRODUCTION

The following data is part of a premarket notification filed by Sofradim Production with the FDA for Modification To Parietex Composite (pco) Mesh.

Pre-market Notification Details

Device IDK040998
510k NumberK040998
Device Name:MODIFICATION TO PARIETEX COMPOSITE (PCO) MESH
ClassificationMesh, Surgical, Polymeric
Applicant SOFRADIM PRODUCTION 5 WHITCOMB AVENUE Ayer,  MA  01432
ContactMary Mcnamara-cullinane, Rac
CorrespondentMary Mcnamara-cullinane, Rac
SOFRADIM PRODUCTION 5 WHITCOMB AVENUE Ayer,  MA  01432
Product CodeFTL  
CFR Regulation Number878.3300 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2004-04-19
Decision Date2004-04-29
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
10884521178465 K040998 000
10884521178458 K040998 000
10884521178472 K040998 000

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