RESTORELLE M, RESTORELLE XL

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

COLOPLAST CORP.

The following data is part of a premarket notification filed by Coloplast Corp. with the FDA for Restorelle M, Restorelle Xl.

Pre-market Notification Details

Device IDK132061
510k NumberK132061
Device Name:RESTORELLE M, RESTORELLE XL
ClassificationMesh, Surgical, Synthetic, Urogynecologic, For Apical Vaginal And Uterine Prolapse, Transabdominally Placed
Applicant COLOPLAST CORP. 1601 WEST RIVER Minneapolis,  MN  55411
ContactTim Crabtree
CorrespondentTim Crabtree
COLOPLAST CORP. 1601 WEST RIVER Minneapolis,  MN  55411
Product CodeOTO  
CFR Regulation Number878.3300 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2013-07-03
Decision Date2013-08-02
Summary:summary

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