RESTORELLE Y CONTOUR MESH

Mesh, Surgical, Synthetic, Urogynecologic, For Apical Vaginal And Uterine Prolapse, Transabdominally Placed

COLOPLAST A/S

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

Pre-market Notification Details

Device IDK140116
510k NumberK140116
Device Name:RESTORELLE Y CONTOUR MESH
ClassificationMesh, Surgical, Synthetic, Urogynecologic, For Apical Vaginal And Uterine Prolapse, Transabdominally Placed
Applicant COLOPLAST A/S 1601 WEST RIVER ROAD N Minneapolis,  MN  55411
ContactTim Crabtree
CorrespondentTim Crabtree
COLOPLAST A/S 1601 WEST RIVER ROAD N Minneapolis,  MN  55411
Product CodeOTO  
CFR Regulation Number878.3300 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2014-01-16
Decision Date2014-02-12
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
05708932553773 K140116 000

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