RESTORELLE POLYPROPYLENE Y 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 Polypropylene Y Mesh.

Pre-market Notification Details

Device IDK112322
510k NumberK112322
Device Name:RESTORELLE POLYPROPYLENE Y 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)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2011-08-12
Decision Date2012-05-17
Summary:summary

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