RESTORELLE POLYPROPYLENE MESH; RESTORELLE POLYPROPYLENE MESH

Mesh, Surgical, Polymeric

COLOPLAST A/S

The following data is part of a premarket notification filed by Coloplast A/s with the FDA for Restorelle Polypropylene Mesh; Restorelle Polypropylene Mesh.

Pre-market Notification Details

Device IDK103568
510k NumberK103568
Device Name:RESTORELLE POLYPROPYLENE MESH; RESTORELLE POLYPROPYLENE MESH
ClassificationMesh, Surgical, Polymeric
Applicant COLOPLAST A/S 1601 WEST RIVER ROAD NORTH Minneapolis,  MN  55411
ContactJanell A Colley
CorrespondentJanell A Colley
COLOPLAST A/S 1601 WEST RIVER ROAD NORTH Minneapolis,  MN  55411
Product CodeFTL  
CFR Regulation Number878.3300 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2010-12-06
Decision Date2010-12-22
Summary:summary

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